Detecting Cancer in Blood

not commercially available in the U.S. Detecting Cancer in Blood Company presentation Safe harbor statement Forward Looking Statements This communi...
Author: Piers Shields
1 downloads 2 Views 3MB Size
not commercially available in the U.S.

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.

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.

1

3/23/2016

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.

not commercially available in the U.S.

2

3/23/2016

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 3

3/23/2016

Colorectal

Source: American Cancer Society, Cancer Facts & Figures 2016, annual figures

Lung

Colorectal cancer (CRC): Early detection saves lives

4

3/23/2016

Diagnosed in Stage I or II

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

CRC: One in three in the USA remains unscreened

35% Unscreened eligible population

65% Screened population

23 to 30 million eligible Americans are not screened for CRC 5

3/23/2016

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%

2002 6

3/23/2016

2008

Source: Data from the BRFSS survey reported in MMWR 60(26)884-889, MMWR 62(44):881-888.

2018

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

3/23/2016

Opportunity for US market expansion

15%

Screening gap

$2 billion* Closing the screening gap towards the 80% goal

80% CRC screening goal by ACS

65%

Screened population

* Annual revenue ex laboratory

8

3/23/2016

High patient preference for blood test

97%

83% of those patients chose a blood test

of patients refusing colonoscopy accepted minimal-invasive test Source: Adler, A., et al. (2014). Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol 14: 183.

9

3/23/2016

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 10

3/23/2016

Epi proColon - Option for non-compliant patients

Colonoscopy

Patient managed based on colonoscopy outcome

Standard of Care Further regular screening

11

3/23/2016

Epi proColon detects tumor-specific DNA in blood

12

3/23/2016

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 68.2% and specificity of 80.0%

 Sensitivity of Epi proColon was 73.2% vs. 68.0% 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 13

3/23/2016

Recent FDA notification* on status of Epi proColon Final approval expected

Epi proColon

would be first and only FDA approved blood-

in Q1/Q2 2016

based colorectal cancer test on U.S. market

Significant milestone

Only minor topics

towards FDA approval

left to be clarified with the agency

* published on Jan 8, 2016 14

3/23/2016

Next steps towards approval Secure reimbursement code

Secure national availability upon launch Train and inform potential laboratory customers Build product inventory to serve initial demand Finalize FDA requirements 15

3/23/2016

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

16

3/23/2016

Strong outreach through multiple sales channels Reference Labs

Epigenomics Polymedco

3/23/2016

Leading hospitals

Academic Medical Centers

Integrated Networks

17

Local medical doctors

Key opinion leaders

Healthcare providers

Ideal partnership for commercial success

Marketing Sales Distribution Customer support Billing Collection

18

3/23/2016

Product supply Reimbursement Regulatory KOLs Medical guidelines

Reimbursement elements

19

3/23/2016

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

Epi proColon® distribution and license agreement for Septin9 in place 20

3/23/2016

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

21

3/23/2016

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.

Liquid biopsy will revolutionize cancer care



Disease management Early detection

Costs

Liquid biopsy Invasiveness

Compliance Repeatability

22

3/23/2016

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

23

3/23/2016

>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 24

3/23/2016

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

18,700,1591 (20.1m fully diluted)

Analyst coverage

Edison, Equinet, First Berlin, Kempen & Co, Maxim

1

As of Feb 29, 2016; 2 According the published voting right notifications

25

3/23/2016

Shareholder structure

BioChain

9.1%2

Abingworth 4.9%2 Free float

86.0%

Expected news flow topics 2016

Start of clinical studies with Epi proLung®

FDA approval

26

3/23/2016

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 27

3/23/2016

Suggest Documents