2016 - Epigenomics AG

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.
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5/4/2016
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.
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5/4/2016
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
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5/4/2016
Colorectal
Source: American Cancer Society, Cancer Facts & Figures 2016, annual figures
Lung
Colorectal cancer (CRC): Early detection saves lives
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5/4/2016
Diagnosed in
Stage I
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; *rounded (13%)
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
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5/4/2016
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%
2006
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5/4/2016
2008
Source: Data from the BRFSS survey reported in MMWR 60(26)884-889, MMWR 62(44):881-888.
2018
Epi proColon receives FDA approval (April 12, 2016)
First and only FDA-approved blood-based
colorectal cancer screening test
Epi proColon® 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).
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5/4/2016
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
5/4/2016
Opportunity for US market expansion
15%
Screening gap
12.3 million patients
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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5/4/2016
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
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5/4/2016
Epi proColon - Option for non-compliant patients
Colonoscopy
Patient
managed
based on
colonoscopy
outcome
Standard of Care
Further
regular
screening
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5/4/2016
Epi proColon detects tumor-specific DNA in blood
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5/4/2016
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% and
specificity of 80%
Sensitivity of Epi proColon
was 73% vs. 68% 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
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5/4/2016
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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5/4/2016
Strong outreach through multiple sales channels
Reference
Labs
Epigenomics
Polymedco
5/4/2016
Leading
hospitals
Academic
Medical
Centers
Integrated
Networks
15
Local
medical
doctors
Key
opinion
leaders
Healthcare
providers
Ideal partnership for commercial success
Marketing
Sales
Distribution
Customer support
Billing
Collection
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5/4/2016
Product supply
Reimbursement
Regulatory
KOLs
Medical guidelines
Reimbursement process underway
CPT code
Health
economics
model
FDA label
granted
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5/4/2016
completed
Tier-1 code
designated
by AMA
Inclusion in
Medical
Guidelines
initiated
National
Coverage
Determination
in preparation
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
China FDA names Epigenomics’ blood-based Septin9 colorectal cancer test a
most innovative medical product for 2015
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5/4/2016
1
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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5/4/2016
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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5/4/2016
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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5/4/2016
>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
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5/4/2016
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
19,108,0091
(20.1m fully diluted)
Analyst
coverage
Edison, Equinet, First Berlin,
Kempen & Co, Maxim
1
As of April 30, 2016; 2 According the published voting right notifications
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5/4/2016
Shareholder structure
BioChain
9.1%2
Free float
90.9%
Expected news flow topics 2016
Start of
clinical
studies with
Epi proLung®
FDA
approval
24
5/4/2016
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
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5/4/2016