Detecting Cancer in Blood

Transcription

Detecting Cancer in Blood
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.
1
9/12/2016
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
9/12/2016
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
9/12/2016
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
9/12/2016
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
9/12/2016
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%)
Targeting deadly cancers
Colorectal Cancer
Lung Cancer
US population
US population
224,390
158.080
134,490
49.190
Annual New Cases
6
9/12/2016
Annual Deaths
Annual New Cases
Sources: American Cancer Society, Cancer Facts & Figures 2016, annual figures.
Annual Deaths
Epi proColon  included in newly issued USPSTF
Guidelines for Colorectal Cancer Screening (June 16)

United States Preventive Services Task
Force (USPSTF) emphasizes the need for
higher screening participation

USPSTF recommends Epi proColon as the
only blood-based colorectal cancer
screening test per Figure 2 of publication

Market confusion caused by the Task Force:
7

Sensitivity reference was from prior version of the assay and not the FDAapproved product

Task Force literature review missed 2 recent peer-reviewed publications
which were part of the FDA review process
9/12/2016
Paradigm shift in colorectal cancer screening
8
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
9/12/2016
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
9
9/12/2016
Epi proColon - Option for non-compliant patients
Colonoscopy
Patient
managed
based on
colonoscopy
outcome
Standard of Care
Continued
Annual
Screening
10
9/12/2016
Epi proColon detects tumor-specific DNA in blood
11
9/12/2016
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%
12
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)
9/12/2016
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
13
9/12/2016
Ideal partnership for commercial success
Marketing
Sales
Distribution
Customer support
Billing
Collection
14
9/12/2016
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
15
9/12/2016
Reimbursement process underway
Inclusion in
Medical
Guidelines
Health
Included in
Economics
USPSTF
Model
FDA Label Completed guidelines
Granted
Apr
May
Jun
2016
2016
2016
16
9/12/2016
HEDIS
Guidelines
Initiated
discussion
with AHRQ
Jul
2016
CPT code
New Tier-1
form code
published in
CMS pricing
book
Oct
2016
National
Coverage
Determination
In discussion
Feb – Aug
2017
CMS reimbursement
National Coverage Determination (NCD):
 Epigenomics has initiated the process and has already conducted the first
informal CMS meeting in July 2016
 Expect formal application to be submitted in August / September 2016
dependent upon CMS feedback
 Review cycle 6-12 months (Potential NCD between February 2017 – August
2017)
Tier 1 Code:
 In their panel meeting in February 2016, the CPT Editorial Panel of the
American Medical Association decided to issue a test specific, tier 1 CPT
code for methylated Septin9 for analysis of colorectal cancer (813X7)
 Cross-walk submitted to CMS for $159 per test reimbursement
 Cross-walk proposal formally supported by AMP, AACC, AMA, and CAP
 Expected determination in October 2016
17
9/12/2016
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
System Costs
1,200
$10.00
1,058
1,000
879
$8.00
800
$8.64
$7.22
$6.00
600
$4.00
400
179
200
-
$1.43
$2.00
$-
No Epi proColon
With Epi
proColon
Incremental
Diagnoses
No Epi proColon
Cancer Diagnoses
•
With Epi
proColon
Incremental
Costs
Per Member Per Month Cost
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.
•
18
9/12/2016
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
9/12/2016
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
9/12/2016
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
9/12/2016
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
9/12/2016
>20 proprietary
biomarkers in colorectal
cancer, lung cancer and
other solid tumor
indications
Test development
and validation of
regulated in-vitro
diagnostic
products
Q2/2016 Key financials
EUR million
Revenue
EBITDA*
EPS
Q2 2016
Q2 2015
Change in %
1.3
(3.5)
(0.16)
0.5
(2.2)
(0.15)
+159%
56%
7%

Revenue growth driven by increase in product revenue of 319%

U.S. revenues based on initial stocking effects – Epigenomics to receive
additional revenue share following in-market sales of Polymedco

EBITDA loss increased primarily due to higher SG&A costs
*adjusted for non-cash expenses related to stock compensation
23
9/12/2016
Liquidity
EUR million
Liquid assets*
June 30,
2016
13.2
Dec 31,
2015
8.6
 Five convertible notes were converted during 6M 2016
 A private placement was executed in Q2 for EUR 6 million (net)
 Conversion of outstanding five convertible notes anticipated in 2H
(EUR 2.6 million)
*cash and cash equivalents incl. marketable securities
Liquid assets currently sufficient to fund operations into 2017
24
9/12/2016
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 June 2, 2016; 2 According the published voting right notifications
25
9/12/2016
Shareholder structure
BioChain
6.0%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



26
9/12/2016
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
27
9/12/2016

Similar documents