Corporate Presentation May 2015

Epigenomics AG
May 2015
www.epigenomics.com
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, 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 forwardlooking 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.
2 | May 2015
 Overview
 Epi proColon®
• Unmet need & commercial opportunity for Epi proColon®
• Commercial strategy
 Epi proLung® and future product opportunities
 Financial Information and Summary
 Appendix
3 | May 2015
DNA Methylation Diagnostic Products for Oncology
Epi proColon®
Epi proLung®
blood-based
colorectal cancer (CRC) screening1,2
tissue assay for
lung cancer diagnosis1
Addressing low compliance to
currently available CRC screening
Aid in difficult to diagnose lung cancer
Potential to be developed into blood based assay
1 CE
4 | May 2015
marked and commercially available in Europe 2 under FDA review and not commercially available in the U.S.
 Overview
 Epi proColon®
• Unmet need & commercial opportunity for Epi proColon®
• Commercial strategy
 Epi proLung® and future product opportunities
 Financial information and summary
 Appendix
5 | May 2015
Fighting a Treatable Disease: Colorectal Cancer
Public Health Impact
Health Economic Impact
90% 5-year survival rate in stages I and II
>136,000 new cases and 50,000 deaths1
USD 14 Bn CRC treatment cost p.a.2
Over a third in late stage disease
Colonoscopy every 10y
or annual FIT3
1 ACS
6 | May 2015
Screening
is key!
25-30 million people
not screened for CRC
Cancer Facts & Figures 2014, 2 Centers for Disease Control. "Vital signs: Colorectal cancer screening, incidence, and mortality ---United States, 2002-2010 " MMWR Morb. Mortal.
Weekly Report. 2011, 60(26):884-889.3 recommendation of the U.S. Preventive Services Task Force (USPSTF) for people aged between 50-75 years,
•Goal: Increase in Screening Participation to 80%+
 Campaign by ACS to get 80% screened by 2018
 Reaching that goal would save over 200,000 lives1
 Simple blood test can significantly contribute to this goal
1 http://onlinelibrary.wiley.com/doi/10.1002/cncr.29336/abstract
7 | May 2015
Blood Testing Increases Compliance
 Demonstrated acceptance of blood test
for CRC Screening1
 Of the 63% who refused colonoscopy
screening, 83% opted for Septin9
blood test
 Surveys in the U.S. confirm these results2
 Patient choice of methods has shown
to increase screening compliance3
1 Study
8 | May 2015
performed at Charité University Hospital, Berlin (Germany): Adler et al, BMC Gastroenterology 2014, 14:183 doi:10.1186/1471-230X-14-183 2 Taber et al. (2012, ASPO):
Preferences for a methylated DNA blood test for colorectal cancer among a multiethnic sample of screened and unscreened adults,
3 Inadomi J et al. Adherence to colorectal cancer screening, a randomized clinical trial of competing strategies, 2012
More Options for Physicians and Patients
Imaging methods
colonoscopy
flexible sigmoidoscopy
virtual colonography
ingestible devices
etc.
9 | May 2015
Stool sampling
fecal occult blood (FOBT)
immunochemical (FIT)
etc.
Blood based
Epigenomics:
methylated Septin9
Epi proColon®: Simple and Efficient for Patients and Customers
 Easy for the patient
part of routine visits; no dietary restrictions
 Easy for the doctor
Septin9 (+): colonoscopy
 Easy for the lab
runs on existing hardware (validated for ABI, Roche)
10 | May 2015
Septin9 (-): return next year
Epi proColon®: Powerful Screening Tool with Flexible Set Up
Epi proColon®
(under US FDA review)
10 ml blood sample
Epi proColon®
test result
(3x15ul)
min. 45 μl DNA
11 | May 2015
Epi proColon® 2.0 CE
(CE marked, CFDA)
+++
test result
positive (+)
test result
positive (+)
- ++
follow-up with
colonoscopy
follow-up with
colonoscopy
negative (-)
negative (-)
- -+
- - -
Epi proColon®: Validated in Clinical Trials
US product1,2
China/EU
product3,4
+++
Sensitivity
68-73%
Sensitivity
75-81%
 Non-inferiority to FIT
- ++
Specificity:
80-82%
Specificity:
97-99%
 Case control studies
- -+
 US data generated in
prospective trials
for FDA submission1
demonstrated in headto-head study2
(FIT sensitivity: 68%)
in Europe and China
using the “2 out of 3”
algorithm3,4
- - -
1 Potter et al. , Clinical Chemistry June 2014 clinchem.2013.221044 “Validation of a Real-Time
PCR-Based Qualitative Assay for the Detection of Methylated Sept9 DNA in Human Plasma“, 2 Approx. 100 CRC cases from screening eligible patients and ~200 prospectively collected
normal controls ; Non-inferiority (sensitivity) to OC-FIT-Chek™ proven in study 3 Case control study performed in Europe, 100 CRC cases, 148 normal controls, 4 Jin et al., accepted for publication
12 | May 2015
Possible Performance Improvement (post-hoc analysis1,2)
+++
positive (+)
(3% of all cases)
- ++
- -+
- - 1 Based
13 | May 2015
“1 out of 3“
or “weak” positives
(15% of all cases)
negative (-)
(82% of all cases)
re-test with FIT:
65% sensitivity
96% specificity
overall combined performance1
re-test
re-test with Epi proColon:
70% sensitivity
90% specificity
overall combined performance2
on post-hoc analysis of FIT/Sept9 comparison study 2 Based on post-hoc analysis of FIT/Sept9 comparison study and retesting of „weak positive“ results with Epi proColon®
Regulatory Status of Epi proColon®
Europe:
 Commercially available since 2012 – growing sales but at low levels since
no active commercial effort underway for the time being – CE marking based
approval in other countries, e.g. Argentina
China:
 Approved in China in December 2014 – commercialized by BioChain
U.S.A.:
 PMA under review by US FDA since early 2013
 Response letter June 2014 – FDA is looking for additional data supporting
the assumption that Epi proColon® will increase compliance to CRC screening
recommendations in the intended use population (non-screening compliant)
 PMA on file – additional data to complete the PMA (no resubmission)
14 | May 2015
Regulatory Status of Epi proColon® - USA
ADMIT Study (Adherence to Minimally Invasive Testing)

Study was conducted with Kaiser Permanente and Geisinger Health Systems

413 subjects in two study arms (Epi proColon® and FIT test)

Epi proColon® showed nearly 100% adherence rate –
significantly higher than stool-based FIT (88%)

Margin of at least 8.2% higher acceptance achieved,
but fell just short of statistical significance

With the observed FIT adherence rate, a margin of 3.2%
would have been sufficient, this was met with statistical significance

Results will be submitted to the FDA in the coming weeks
15 | May 2015
 Overview
 Epi proColon®
• Unmet need & commercial opportunity for Epi proColon®
• Commercial strategy
 Epi proLung® and future product opportunities
 Financial information and summary
 Appendix
16 | May 2015
Joint Commercialization Agreement with Polymedco
 Market leader in the CRC screening field
>10M FIT tests p.a. sold
 Ideally positioned (CRC focus) to address
>1,500 existing laboratory customers
Epigenomics:
Manufacturing
IP
Joint Efforts:
Regulatory
Key accounts
Clinical
Reimbursement
Medical networks
Strategic
marketing
PRODUCT
CHANNEL
Polymedco:
Marketing
Sales
Distribution
Customer support
Billing
Collection
17 | May 2015
Value Chain of Septin9 based CRC Screening
pays COGS1
- Guidelines -
profit share
sells to
laboratories
US$ 75-902
orders
test
Reference Laboratories
invoices
payers
provides
result
Healthcare Professionals
US$ 1412
- Payors 1
18 | May 2015
Cost of goods sold (COGS) 2 Company estimates
Blood Testing to drive Market Expansion
 Health economic benefit demonstrated1
Septin9 based screening proven to be cost-effective
Incremental U.S. market opportunity
estimated in excess of USD 1 Bn annually2
1 U.
19 | May 2015
Ladabaum et al. 2 Company and Analyst estimates
Reimbursement
Medical Guidelines
first 6
months
generate health economic data
expert groups /
medical societies
7-18
months
ensure reimbursement
selected KOL studies
>18
months
Key Elements for Successful U.S. Market Penetration
governmental endorsement
guideline inclusion
20 | May 2015
Strategic Collaboration with BioChain in China
 Stage 1: Epi proColon® approved in China by CFDA1
 BioChain to start commercialization in 2015
 Chinese guidelines for CRC screening in draft status
 Pricing and reimbursement discussions underway
 Stage 2: License to develop and commercialize Septin9 IVD tests
 Development underway, clinical studies started
 Epigenomics has the rights for the rest of the world
Enormous market opportunity –
CRC incidence increasing –
290M people screening eligible in China
1
21 | May 2015
China Food and Drug Administration (CFDA)
 Overview
 Epi proColon®
• Unmet need & commercial opportunity for Epi proColon®
• Commercial strategy
 Epi proLung® and future product opportunities
 Financial information and summary
 Appendix
22 | May 2015
Epi proLung®: Current Status in the Diagnosis of Lung Cancer
 Biomarker: methylated SHOX2 gene1
 Validated as reflex test for the diagnosis
of lung cancer in bronchial lavage
 Currently marketed as
CE-marked IVD test in Europe
Lung cancer diagnostic work - up including measurement of SHOX2 gene
methylation
 Prospective study demonstrated that
Epi proLung® testing provides
additional information in cases where
cytology is negative or inconclusive2
 The combination of both methods
resulted in clinical sensitivity of 98%
1 Kneip
23 | May 2015
et al., „SHOX2 DNA Methylation Is a Biomarker for the Diagnosis of Lung Cancer in Plasma”. Journal of Thoracic Oncology, Vol 6, Number 8, August 2011
2 Klauschen et al., „Performance of Epi proLung in combination with cytology in bronchial lavage samples from clinical routine“. In preparation
Epi proLung® Next Steps
 Development of blood-based version
 Applications in treatment response monitoring
 Study demonstrated mSHOX2 to be sensitive
and specific for therapy monitoring and
early detection of tumor response1
 More rapid and sensitive determination
than CT scan
 Multi-centric study with larger patient
population planned for verification
 Possible initial application in follow-up of
positive results in low dose spiral CT
 Attractive future opportunity in screening of high risk patients
1
24 | May 2015
Fleischhacker et al. PLoS ONE 10(2): e0118195. doi:10.1371/journal.pone.0118195
R&D Capabilities and Future Product Opportunities
Epigenomics
core capabilities
Biomarker discovery,
confirmation and selection
IVD test development,
validation and regulatory
>20 proprietary prognostic, predictive, response, diagnostic,
and screening biomarkers in cancer indications
 Potential to evaluate and clinically validate in collaboration with BioChain
 Broad IP protection with 70 active patent families: protection along the value chain
 Epigenetic biomarker discovery and IVD development capabilities
25 | May 2015
 Overview
 Epi proColon®
• Unmet need & commercial opportunity for Epi proColon®
• Commercial strategy
 Epi proLung® and future product opportunities
 Financial information and summary
 Appendix
26 | May 2015
Key Financial Information
Q1 2015
Q1 2014
367
407
EBIT (Operating Result)
-3,164
-2,000
Net loss
-3,164
-2,240
Cash consumption
-2,288
-1,475
Mar 31, 2015
Dec 31, 2014
6,421
7,495
(in € thousand)
Revenue
(in € thousand)
Liquid Assets*
* incl. marketable securities
 Liquid assets to fund operations until expected US launch
 Up to EUR 7.9M additional cash inflow in 2015 possible from
conversion of outstanding bonds (EUR 1.5M so far in 2015)
 Capital Increase up to EUR 5M
 Subscription price EUR 5.12, subscription period May 13, 15 - May 27, 15
27 | May 2015
Shareholder Structure
Type of shares
Security code number
ISIN
registered shares
A11QW5
Stock Exchange
Type of program
Sponsored Level 1 ADR
Program
Ratio
Abingworth 4.9%
DE000A11QW50
Frankfurt Stock Exchange,
Prime Standard: ECX
Freefloat
1 ADR = 5 shares
Ticker symbol
EPGNY
Total Shares
Outstanding
16.092.1971
(19.2m fully diluted)
Analyst coverage
86.0%
Edison
Equinet
First Berlin
Kempen & Co
Maxim
1
28 | May 2015
9.1%
BioChain
As of April 30, 2015
Why Invest in Epigenomics....
Epi proColon®
the world’s first IVD blood test
intended for CRC screening:
Extensively validated
Proven utility
Approved in Europe and
China
Under FDA review
29 | May 2015
Not for sale or diagnostic use in the United States of America
Thank you for your attention!
Contact Investor Relations
Europe
U.S.A.
Antje Zeise
Manager Investor Relations
Epigenomics AG
T. +49 30 24345 386
[email protected]
Brian Korb
Managing Director
The Trout Group LLC
T. +1 646 378 2923
[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
www.epigenomics.com
 Overview
 Epi proColon®
• Unmet need & commercial opportunity for Epi proColon®
• Commercial strategy
 Epi proLung® and future product opportunities
 Financial information and summary
 Appendix
31 | May 2015
Methylated Septin9 – Blood Based Test for CRC Detection
 Simple blood-based tests widely seen as
best way to close the “screening gap”
 Epi proColon® is based on a single
epigenetic biomarker: methylated Septin9
 Septin9 in CRC tissue fully methylated in
>95% of all cancers
 High analytical sensitivity (6pg/ml),
specific for colorectal cancer
 Equal capability to detect left and right
sided cancerous lesions
32 | May 2015
Comparison of non-invasive Screening Tests in the U.S.
Colonoscopy
FOBT
FIT
(multiple)
Stool DNA
(Cologuard™)
Sample
Structural
exam
Stool
Stool
Stool
Location of
Testing
Endoscopy
Center
Clinical Lab
Clinical Lab
Endoscopy
Center
Clinical Lab
Clinical Lab
US Pricing
(varies
globally)
Companyowned CLIA
Laba
$800-$3160b
(variable rates)
$4.54c
$22.22c
$599d
$550-$794b
(variable rates)
$300-400e
$135-$150f
Sensitivity
(for CRC)
95%g
70%g
(64-80%)
65.8-88.2%h
92.3%i
70-90%j
(lesion-size
dependent)
61-72%k
73.3%l
Specificity
95%g
95%g
(87-90%)
89.7-94.6%h
86.6%i
86.0%j
66-77%k
81.5%l
LDT
Under FDA
PMA Review
US:LDT /
EU:IVD
Availability
Through
specialist
IVD–FDAm
cleared
IVD–FDA
cleared
IVD–FDA
approved
CT
Blood RNA
Colonography (ColonSentry)
Virtual Imaging
Blood
Exam
Through
specialist
Septin9
(multiple)
Blood
CLIA – Clinical Clinical Laboratory Improvement Amendments – US Center for Medicare & Medicaid Services bCost to insurance, endoscopy center, no polyp removed; Healthcare Bluebook fair pricing
(Consumer Reports). c Maximum Medicare reimbursement rate.d Exact Sciences, published reports. eZehr L et. al. New York approval of ColonSentry, February 2012. f Cost of CE marked EU and US LDT
Septin9 tests; cost to patient may not be covered by insurance. g Zauber AG et. al. Technology assessment report, project ID CRCC0608, 2009. h Colorectal Cancer Screening (PDQ®) National Cancer
Institute at National Institutes of Health, newer FOBTs: nonrandomized controlled trial evidence, 2014. i Imperiale T et. al. New Engl J Med. 2014, 370(1287-1297). j Colorectal Cancer Screening (PDQ®)
National Cancer Institute at National Institutes of Health,virtual colonoscopy (computer tomographic [CT] colonography), 2014. k Ganepola AP et. al. World J Gastrointest Oncolo. 2014, 6(4):83-97. l
Johnson et. al. PloS One9(6): e98238. doi:10.1371/journal.pone.0098238 m IVD – In Vitro Diagnostic
a
33 | May 2015
Comparison Study Top Line Data:
Cancer Detection by Stage from head-to-head FIT/Septin9 trial
Epi proColon®
pT0/Tis
pT1
pT2
pT3
pT4
pTx
unknown
TOTAL
2/3
6/11
10/13
-
-
-
0/1
18/28
64.3% (45.8-79.3%)
Stage II
-
-
-
14/18
2/2
-
-
16/20
80.0% (58.4-91.9%)
Stage III
-
0/1
0/2
14/19
1/1
-
-
15/23
65.2% (44.9-81.2%)
Stage IV
-
2/2
-
0/1
6/6
1/1
3/3
12/13
92.3% (66.7-99.6%)
Unknown*
-
-
-
-
-
3/3
10/14
13/17
76.4% (52.7-90.4%)
2/3
8/14
10/15
28/38
9/9
4/4
13/18
74/101
73.3% (63.9-
Stage 0 / I
TOTAL
80.9%)
*…Staging information incomplete or unavailable
FIT
pT0/Tis
pT1
pT2
pT3
pT4
pTx
unknown
TOTAL
0/3
5/11
11/13
-
-
-
1/1
17/28
60.7% (42.4-76.4%)
Stage II
-
-
-
14/18
2/2
-
-
16/20
80.0% (58.4-91.9%)
Stage III
-
1/1
1/2
16/19
1/1
-
-
19/23
82.6% (62.9-93.0%)
Stage IV
-
1/1
-
0/1
4/6
1/1
1/3
7/12
58.3% (32.0-80.7%)
Unknown*
-
-
-
-
-
1/3
6/11
7/14
50.0% (26.8-73.2%)
0/3
7/13
12/15
30/38
7/9
2/4
8/15
66/97
68.0% (58.2-
Stage 0 / I
TOTAL
*…Staging information incomplete or unavailable
34 | May 2015
76.5%)

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