Download Detecting Cancer in Blood

Detecting Cancer
in Blood
Company Presentation
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1
11/23/2016
First FDA approved blood-based colorectal cancer
screening test
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.
2
11/23/2016
Epi proColon receives FDA approval (April 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 were offered and decline colonoscopy and stoolbased fecal immunochemical tests (FIT)
3
11/23/2016
Colorectal cancer: One in three
in the USA remains unscreened
35%
Stagnant screening rate
over the past years
60%
Unscreened
eligible
population
63%
65%
65%
2010
2012
Screening
gap
Significant portion of population remains unscreened
80%
65%
Screened population
2006
2008
2018
About 23 million eligible Americans are not screened for
colorectal cancer
Sources: Centers for Disease Control and Prevention, “Vital Signs”, November 2013; American Cancer Society Cancer
4
11/23/2016
Facts and Figures, 2015. Data from the BRFSS survey reported in MMWR 60(26)884-889, MMWR 62(44):881-888.
Colorectal cancer: Early detection saves lives
5
Diagnosed in
Stage I
Diagnosed in
Stage IV
9 out of 10 survive
1* out of 10 survive
5 years
5 years
11/23/2016
Source: American Cancer Society, Cancer Facts & Figures 2015; *rounded (13%)
Targeting deadly cancers
Colorectal Cancer
Lung Cancer
US population
US population
224,390
158.080
134,490
49.190
Annual New Cases
6
11/23/2016
Annual Deaths
Annual New Cases
Sources: American Cancer Society, Cancer Facts & Figures 2016, annual figures.
Annual Deaths
Paradigm shift in colorectal cancer screening
7
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
11/23/2016
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
8
11/23/2016
Epi proColon - Option for non-compliant patients
Colonoscopy
Patient
managed
based on
colonoscopy
outcome
Standard of Care
Continued
Annual
Screening
9
11/23/2016
Epi proColon detects tumor-specific DNA in blood
10
11/23/2016
Test performance established in major studies
Prospective
pivotal 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%
11
FIT
comparison
study
 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
* Included in “Instructions for Use” (FDA approval)
11/23/2016
U.S. commercialization with partner
Nation-wide distribution to target labs with Polymedco: early adopters include
LabCorp, ARUP, and Dartmouth Medical Center
All incentives
aligned between
labs, partner and
Epigenomics
HQ
Polymedco is the
biggest distributor
of colorectal cancer
screening tests
in the U.S.
Ideally positioned
(colorectal cancer
focus) to address
over 1,000 existing
laboratory
customers
U.S. chart with target labs only illustrative
12
11/23/2016
Ideal partnership for commercial success
Marketing
Sales
Distribution
Customer support
Billing
Collection
13
11/23/2016
Product supply
Reimbursement
Regulatory
KOLs
Medical guidelines
Enabling labs to become part of the colorectal
cancer screening solution
Reference
Labs
Epigenomics
Polymedco
Local
medical
doctors
Leading
hospitals
Academic
Medical
Centers
Integrated
Networks
Key
opinion
leaders
Healthcare
providers
As an example of the breadth of Epi proColon’s current sales framework, LabCorp
has >1,000 sales representatives that will be trained on the assay
14
11/23/2016
Q3 Commercial highlights
United States
 Won Sonic Labs in Q3 => 4 out of 6
largest labs now offering
methylated Septin 9 testing
Lab
Septin 9
LabCorp

Quest

ARUP

Sonic


LabCorp trained over 1,000 person sales team in Q3 to present Epi proColon to
individual MDs

First national advertisement appeared in “USA Today” Cancer insert in
September
South-East Asia
 Exclusive distribution agreement signed for Thailand, Vietnam, Malaysia &
Singapore with distributor SPD Scientific PTE Ltd. based in Singapore
15
11/23/2016
Reimbursement process underway
FDA Label
Granted
Tier 1 CPT
code
Jan ‘17
Inclusion in
Medical
Guidelines
 ACS
 USPSTF
correction
 ACG
HEDIS
Guidelines
National
Initiated
Coverage
Determination discussion
with AHRQ
 NCD
 Legislation
Typically 12-24 month process
Private Payor
Contracts
These happen
continuously
Introduction of Bipartisan 2016 Colorectal Cancer
Detection Act

Legislation aims to provide coverage under the Medicare program for
FDA-approved qualifying colorectal cancer screening blood-based tests

Bipartisan legislation introduced by Congressman Donald M. Payne, Jr. (DNJ) and Charles Dent (R-PA). Additional co-sponsors include John Delaney
(D-MD) and Lenard Lance (R-NJ).

Expert panel:"Screening the Unscreened: New Approaches to Reaching
the Underserved to Prevent Colorectal Cancer” included leading experts
within the Colorectal Cancer and gastroenterology community

Legislation is unique opportunity to provide millions of unscreened,
underserved Americans access to colorectal cancer screening
17
11/23/2016
Cost effectiveness of Epi proColon use in treatment
Assuming a one million member population, incorporating Epi proColon into
the treatment paradigm to reach 80% screening compliance:
Number of Cancer Diagnoses
1,200
1,000
System Costs
$10,00
1,058
$8,00
879
800
$8,39
$7,22
$6,00
600
$4,00
400
179
200
$2,00
$1,17
$0,00
No Epi proColon
With Epi
proColon
Incremental
Diagnoses
No Epi proColon
Cancer Diagnoses
With Epi
proColon
Incremental
Costs
Per Member Per Month Costs
Net Benefit = ~$53M Cost of Cancer - ~$42M of Screening Costs = ~$10M benefit
•
Assumptions: Out of an assumed population of one million members, 165,751 are assumed to be screening eligible. Incremental costs to system are assumed over a three-year horizon.
•
With Epi proColon volume allocation: 15% Epi proColon; 15% FIT; 50% Colonoscopy; 20% No Screening.
•
No Epi proColon volume allocation: 15% FIT; 50% Colonoscopy; 35% No Screening.
•
Source: Company Medical Economic Model.
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 Colorectal Cancer
Screening Guidelines
China FDA names Epigenomics’ blood-based Septin9 colorectal cancer test a
most innovative medical product for 2015
19
11/23/2016
1
China Food and Drug Administration (CFDA)
High medical need in lung cancer diagnosis

With 1.59 million deaths in 2012, lung cancer is the leading cancer
killer worldwide (WHO, 2012)

Unmet clinical need in lung cancer diagnosis:
– Limit number of people screened
with low dose CT to those with high risk
20
–
Low dose CT leads to 27% false positives
–
Ability to determine which nodules
are likely to be cancerous before
sending the patient to further
invasive diagnostic procedures
11/23/2016
blood test for detection of lung cancer
About lung
cancer
 Lung cancer is
#1 cancer killer
worldwide
 High medical
need for
minimally
invasive tests
21
11/23/2016
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.
R&D strategy
Broad IP protection with
over 50 active patent families
3
2
1
Biomarker
discovery,
confirmation and
selection
22
11/23/2016
>20 proprietary
biomarkers in colorectal
cancer, lung cancer and
other solid tumor
indications
Test development
and validation of
regulated in-vitro
diagnostic
products
Q3/2016 Key financials
EUR million
Revenue
EBITDA*
EPS
Q3 2016
Q3 2015
Change in %
0.9
(2.5)
(0.11)
0.5
(2.4)
(0.14)
+83%
-4%
+16%

Revenue growth driven by increase in product revenue of 95%

YTD revenues influenced by initial stocking effects in the U.S.

EBITDA* remains consistent with Q3 2015 level

EPS improved due to increased number of shares outstanding
*adjusted for expenses related to stock compensation
23
11/23/2016
Revenue and EBITDA outlook 2016
Revenue
EBITDA*
Revenue outlook narrowed to EUR 3.5m to 5.0m
driven by U.S. launch of Epi proColon®
EUR -9.5 to -10.5 million; planned ramp up
of U.S. commercial launch and strategic
financing alternatives
*adjusted for expenses related to phantom stock programs
24
11/23/2016
Liquidity
EUR millions
Liquid assets*
Sep 30,
2016
7.3
Dec 31,
2015
8.6
 Additional cash-inflow expected in Q4/2016 from:
 Recent capital increases (EUR 7.1 million gross proceeds)
 Conversion of outstanding five convertible notes (EUR 2.6 million)
Liquid assets currently sufficient to fund operations through 2017
*cash and cash equivalents incl. marketable securities
25
11/23/2016
Significant investments by Chinese investors
 Issuance of around 1.5 million new shares by way of private placement
announced on November 7 and November 16, 2016
 Shares were subscribed by Chinese investors BioChain, SummitView
Capital and Cathay Fortune International Company
 BioChain (partner for commercialization in China) continues its
participation and expands its leading shareholder position
 Combined shareholding exceeds 15% of total share capital
 Gross proceeds of around EUR 7.1 million used to finance current
operations and to expand U.S commercialization capacities for
Epi proColon
26
11/23/2016
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
20,544,0091
(21.6m fully diluted)
Analyst
coverage
Edison, Equinet, First Berlin,
goetzpartners, Maxim
1
As of September 30, 2016; 2 According the published voting right notifications
27
11/23/2016
Shareholder structure
BioChain
9.3%2
Free float
90.9%
Investment highlights
Problem:
35% of eligible patients unscreened for
colorectal cancer i.e. unable or unwilling to
utilize colonoscopy or stool based products

Opportunity:
23.5M eligible patients in the U.S.

Solution:
Epi proColon® - First FDA approved blood
based colorectal cancer screening test
Offering:
Epi proColon® enables health systems and
their partners to participate in colorectal
cancer via their high complexity CLIA labs
Results:
Significant growth opportunity built upon CostEffective and Scalable Business Model



28
11/23/2016
Thank you for your attention!
Contact Investor Relations
Peter Vogt
Vice President
Corporate Communications & Investor Relations
Phone: +49 (0) 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
29
11/23/2016