Title: Epigenomics Corporate Presentation
1Epigenomics Corporate Presentation
2Safe 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
forward-looking statements to reflect future
events or developments.
3Our Mission is...
... to build a world-leading cancer molecular
diagnostics company based on DNA methylation.
4Investment Highlights
- Unique technology to address multi billion cancer
molecular diagnostics market - Combined market opportunity in excess of 4.8
billion by products under development - Colon cancer screening test Epis first blood
based test to enter reference lab market in the
US in 2008, and as IVD test market not before
2010 market potential 3 billion (IVD test) - Clinical proof-of-concept for prostate and lung
cancer screening with market potential of 1
billion and 0.8 billion, respectively - Attractive cancer specialty diagnostics products
addressing niche markets with high medical need
market launches in 2008 - Full control and ownership of all products
- Worlds leading technology biomarker IP
portfolio in DNA methylation - Validated biomarkers in thousands of patient
samples and numerous clinical studies - Lower regulatory development risks vs.
therapeutics - Non-exclusive licensing model to optimize speed
to market, market penetration and peak sales - Strategic partnerships with Qiagen (preanalytics)
and Affymetrix (microarrays) - Ongoing RD partnerships with JJPRD, Centocor,
Merck Inc., PMRL, etc. - Highly experienced management team combining
technological expertise with experience of
bringing products to market
5Recent Highlights
6Experienced Management Team to Execute on Our
Strategy
EXECUTIVE BOARD
Oliver Schacht, PhDCFO
Geert Walther Nygaard CEO
Dr. Kurt BerlinCSO
Christian Piepenbrock COO
CLINICAL SOLUTIONS
DIAGNOSTICS
CORE FUNCTIONS
Andrew Sledziewski, PhD Senior VP RD and
Diagnostics
Mike Wandell, PhD Senior VP Clinical, Regulatory
Quality
Albert Weber Senior VP Finance, Accounting
Controlling
Dr. Achim Plum VP Corporate Communications
Christina Dahlstroem, PhD Senior VP Clinical
Solutions
7DNA Methylation Provides Unique Advantages
- Biologically relevant
- Stable natural modification of DNA
- Fundamental to gene regulation
- Established field of science
- Highly informative
- Changes in cancer and other diseases
- Rich source of biomarkers for diagnosis,
prognosis, and drug response prediction - Robust
- Simple and technically robust detection and
quantification - Works on tissues or in body fluids
- Stable in routine sample processing
- Proprietary
- Epigenomics owns leading portfolio of DNA
methylation technologies - Epigenomics works with proprietary biomarkers
OFF 0
ON 1
Methylcytosine 5mC
Cytosine C
8DNA Methylation Convenient Application to
Molecular Diagnostics
- Target group cancer patients
- For disease prognosis drug response prediction
- Routine tissue sample (surgical/ biopsy) prepared
for examination by pathologist - Robust signal
- Easy to quantify without additional reference
markers - Proprietary quantitative detection technologies
Tumor tissue for Cancer Molecular Classification
- Body fluids for cancer early detection
- Target group healthy (asymptomatic) population
- Detection of tumor DNA in body fluids by tumor
specific methylation pattern - Routine blood plasma or urine sample
- Highly sensitive proprietary biomarker detection
technology - Clinical proof-of-concept in colorectal,
prostate, and lung cancer
9Streamlined Product Development Pipeline
Blood/urine-Based
Tissue-based
As of June, 2007
10Colorectal Cancer Screening The Business Case
1 USA, Europe, Japan 2ACS American Cancer
Society 3Combined for all IVD companies in
target population Assumes 50 overall screening
compliance testing every 24 months US100 150
price to payor 4FOBT Fecal Occult Blood Test
11Colorectal Cancer Screening Competitive Landscape
Epigenomics has a very competitive product
1) Davies. RJ et al. (2005). Nat Rev Cancer
5199-209. 2) Collins, JF et al. (2005).
Annals of In Med Jan 14281-5. 3) Imperial, TF et
al. (2004). N Engl J Med. 3512704-14. 4)
Lofton-Day, C et al. (2007) AACR Annual Meeting
2007.
Clinical experts opinion A
blood test for colorectal cancer could greatly
improve compliance. With ? 60 sensitivity such
a test would be superior to current IVD tests.
12Colorectal Cancer Screening Commercialization
Strategy
- Screening tests require strategic industry
partners - Mass marketing to labs, GPs, patients and health
care providers - Securing reimbursement
- Inclusion into screening guidelines
- High-throughput platform
- Epigenomicss development commercialization
strategy for screening tests - Progress generic part of IVD development (assay
procedure) - Fast market access through launch in US reference
laboratory - Non-exclusive partnering of screening pipeline
with Dx industries players for IVD kit
13Colorectal Cancer Screening Next Steps in
Product Development
Mid 2007
Epigenomics
Research phase
Launch 2008
Assay procedure development
Reference Lab Transfer
Partner 1 H2 2007 Sign agreement 2008 Start of
kit development
Launch 2010
Clinical Regulatory
IVD Kit Dev.
Launch 2010/11
Clinical Regulatory
IVD Kit Dev.
Partner 2
Launch 2011/12
Clinical Regulatory
IVD Kit Dev.
Partner 3
Current Epigenomics Management Estimates
Launches not expected before years given
14Colon, Prostate and Lung Cancer Building a
Cancer Screening Business
1 Algorithm optimized for specificity or
sensitivity 2 USA, Europe, Japan 3 Combined
for all IVD companies in target population 50
overall screening compliance testing every 24
months US100 150 price to payor 4 excluding
high risk population of smokers 5 Current
Epigenomics estimate for earliest possible
product launch
15Prostate and Lung Cancer Building a Cancer
Screening Franchise
- Having multiple screening parameters for a
generic assay procedure increases attractiveness
of partnering opportunity - Leveraging investments in assay procedure and
platform development - Lower incremental cost/shorter development
timeline - Future growth through highly attractive product
opportunities - Marketing sales synergies
Colon cancer screening
Research phase
Assay procedure development
B
Launch
Clinical Regulatory
IVD Kit Dev.
K
Research phase
B
Launch
Clinical Regulatory
IVD Kit Dev.
K
Prostate cancer screening
Research phase
B
Launch
Clinical Regulatory
IVD Kit Dev.
K
Lung cancer screening
16Specialty Cancer Diagnostic Tests
- Support of cancer management
- Addressing high-risk groups and cancer patients
- Body fluid or tumor tissue tests
- Focused marketing to specialists
- Development commercialization by Epigenomics
- Early market access via reference laboratories
- Tissue test platform developed in strategic
partnerships with Qiagen and Affymetrix
17Specialty Cancer Diagnostics Tests
1 Patients who underwent prostatectomy in USA,
Europe, Japan 2Patients with a personal history
of colorectal cancer in the US3 for target
group Assumes price to patient USD 500-1,000
compliance 754 for target group, Assumes price
to patient USD 100-150 compliance 50 annual
testing
18Update on Expected News-Flow 2007/2008
19FY 2007 Financial Guidance
- Revenues expected to be broadly in line with 2006
revenues from partnerships and licensing (EUR 3.5
million) - Revenue recognition under IFRS is heavily
dependent on exact partnering deal structures and
terms - EBIT expected to be similar to 2006 actual of EUR
(15.8) million - Cash flow from operations to be well below 2006
level of EUR (14.4) million at around EUR (12)
million for FY 2007 - Financing Prepared to raise new equity capital
in the coming 12 months. Exact timing will
depend on progress in executing the strategy,
structuring of an IVD deal, and prevailing market
conditions.
20H1 2007 Key Figures I
21H1 2007 Key Figures II
Including marketable securities Includes 6
employees at Epi AG that still need to be shown
for legal reasons
22Shareholders Equity
Notional par value per share EUR 1.00
After options exercised and forfeited
23Thank You for Your Attention
- CONTACT INFO (IR/PR)
- Dr. Achim Plum
- VP Corporate Communications
- T 49 30 24345 368
- achim.plum_at_epigenomics.com
- General Information
- contact_at_epigenomics.com
- www.epigenomics.com
- TICKERS
- Bloomberg ECXGR
- Reuters EXXG.DE
- Thomson ONE ECX-XE