Epigenomics AG · GETTEX:ECX
Epigenomics — FY2013 Earnings Presentation
25 slides from Epigenomics's earnings presentation, Mar 28, 2014
Slide 1: FY 2013 Press Conference & Analyst Call
FY 2013 Press Conference & Analyst Call Frankfurt, Germany March 28, 2014 www.epigenomics.com
Slide 2: Safe Harbor
Safe 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, uncer
Slide 3: FY 2013 Press Conference & Analyst Call Hosted by Thomas Taapken
FY 2013 Press Conference & Analyst Call Hosted by Thomas Taapken, CEO/CFO • Date & Time: Friday, March 28, 2014, 1:00 pm (CET) Press • Conference language: German Conference • Venue: equinet Bank AG („Bilanzpresse- Gräfstraße 97 60487 Frankfurt am Main Konferenz“) Germany • Date & Time: Friday, Marc
Slide 4: Contents
Contents Key Financials 2013 & Financial Outlook 2014 Progress with Epigenomics‘ Product Portfolio Regulatory Status of Epi proColon® & Next Steps Summary 4 | March 28, 2014
Slide 5: Guidance for FY 2013 Achieved
Guidance for FY 2013 Achieved Year-end Results Year-end Results Guidance 2013 2013 2012 Expected to slightly Revenue EUR 1.6M EUR 1.0M increase Expected to improve EBIT EUR -7.3M EUR -12.1M significantly In the range of Net loss EUR 7.4M EUR 12.2M EUR 6.5 - 7.5M Cash EUR 6.5 - 7.5M EUR 6.5M EUR 10.9
Slide 6: 2013 Key Financials: Revenue, Operating Result and Net Loss
2013 Key Financials: Revenue, Operating Result and Net Loss of the Period 2011 2012 2013 Company revenue comprises: vs. 2012 4 Product sales (EUR 649k) +60% 2 Licensing income (EUR 425k) +10% 0 1.4 1.0 1.6 R&D payments (EUR 514k) +108% -2 Increased revenue mainly due to the new -7.4 strate
Slide 7: 2013 Key Financials: Operational and Other Costs
2013 Key Financials: Operational and Other Costs 2011 2012 2013 20 R&D costs significantly declined in 2013 18 compared to 2012 when the execution of the FIT comparison study expanded the 16 Company’s operating activities 0.3 14 5.9 SG&A costs decreased mainly due to a •million EUR 12 5.5 sharp
Slide 8: 2013 Key Financials: Balance Sheet & Cash Flow
2013 Key Financials: Balance Sheet & Cash Flow Liquid assets at YE 2013 were EUR 8.0M (YE 2012: EUR 2.7M) Cash consumption in 2013 amounted to EUR 6.5M (2012: EUR 10.9M) and was at the lower end of Epigenomics’ 2013 prognosis 34 employees at year-end 2013; new hires planned predominantly in th
Slide 9: Capital Measures in 2013
Capital Measures in 2013 Raised EUR 12.5 million in gross proceeds through the issuance of shares and convertible securities in 2013 Secured financing of operations beyond potential FDA approval of Epi proColon® New shares issued Number of shares Gross proceeds outstanding in million Capital inc
Slide 10: Our Share in 2013
Our Share in 2013 Level 1 American Depositary Receipt (ADR) program established Positive share price performance since August 2013 Current shareholder structure: 14.43% 80.47% 19.53% As of March 28, 2014: Abingworth 13,510,892 shares 5.1% Gilbert outstanding Gerber 10 | March 28, 2014
Slide 11: Financial Outlook 2014
Financial Outlook 2014 All expectations are provided under the condition of a regulatory approval for Epi proColon® by the FDA soon after the Advisory Committee Meeting. Revenue expected to slightly increase, driven by: • IVD product sales (direct and through distributors), especially if FDA appro
Slide 12: Contents
Contents Key Financials 2013 & Financial Outlook 2014 Progress with Epigenomics‘ Product Portfolio Regulatory Status of Epi proColon® & Next Steps Summary 12 | March 28, 2014
Slide 13: Epi proColon®
Epi proColon® Addressing low compliance to currently available CRC screening The world’s first IVD blood test suitable for CRC screening: extensively validated in clinical trials proven utility in CRC early detection available as IVD in Europe under FDA review for the US market Not for sale
Slide 14: Progress in the Commercialization of Epi proColon®
Progress in the Commercialization of Epi proColon® Broad strategic collaboration signed with BioChain; BioChain acquired an exclusive license to develop and commercialize Septin9 tests for CRC screening in China. Stage 1: Initiation of 2 major patient clinical studies with the goal of gaining Ch
Slide 15: Joint Commercialization Agreement with Polymedco for the U.S.
Joint Commercialization Agreement with Polymedco for the U.S. Polymedco is U.S. market leader in the colorectal cancer screening field - $50m p.a. plus in sales Polymedco is ideally positioned (CRC focus) to address 1500+ existing CRC customers Epigenomics to transfer product at cost, gross ma
Slide 16: Epi proLung® - Market Introduction
Epi proLung® - Market Introduction CE-marked, marketed in Europe and Asia Biomarker: methylated SHOX2 gene Reflex test for the diagnosis of lung cancer Potential to develop into blood-based assay Progress in 2013 / 2014 Signed licensing and supply agreement with Kindstar for Epi proLung® i
Slide 17: R&D Capabilities and Future Product Opportunities
R&D Capabilities and Future Product Opportunities •core capabilities Biomarker discovery, IVD test development, confirmation and selection validation and regulatory >20 proprietary prognostic, predictive, response, diagnostic, and screening biomarkers in cancer indications Potential to evaluate
Slide 18: Contents
Contents Key Financials 2013 & Financial Outlook 2014 Progress with Epigenomics‘ Product Portfolio Regulatory Status of Epi proColon® & Next Steps Summary 18 | March 28, 2014
Slide 19: Regulatory Status of Epi proColon® in the U.S.
Regulatory Status of Epi proColon® in the U.S. PMA submitted to the FDA in early 2013 Panel meeting was held on March 26, 2014 Proposed Intended Use (summary): Epi proColon is a qualitative in vitro diagnostic test for the detection of methylated Septin9 DNA in EDTA plasma derived from patient w
Slide 20: Recommendations of the Advisory Committee
Recommendations of the Advisory Committee FDA Advisory Committee votes favorably that the benefits of Epi proColon® outweigh the risks The panel voted on three questions: The Advisory Committee members voted 9 to 0 favorably, with one abstention, in assessing whether there is reasonable assura
Slide 21: Next Steps
Next Steps Meeting with the PMA review team of the FDA Discussion of the final product labeling and the design of the planned post-approval study Meeting will be held within the next four to six weeks After this meeting, Epigenomics will provide a detailed update about its planned next steps
Slide 22: Three Pillars of U.S. Market Penetration
Three Pillars of U.S. Market Penetration Commercial Reimbursement Guidelines first 6m expert groups / LDT to IVD switch health economic data medical societies 6-18m early adopters reimbursement KOL studies Polymedco customer >18m governmental support guidelines inclusion base Pre-approval situatio
Slide 23: Contents
Contents Key Financials 2013 & Financial Outlook 2014 Progress with Epigenomics‘ Product Portfolio Regulatory Status of Epi proColon® & Next Steps Summary 23 | March 28, 2014
Slide 24: Summary
Summary Financial results & corporate update FY 2013 financial guidance fully achieved Secured financing of operations beyond potential FDA approval of Epi proColon® Appointment of Dr. Uwe Staub to the Executive Board as Chief Operating Officer Commercial activities Important achievements in
Slide 25: Thank you for your attention!
Thank you for your attention! Contact Investor Relations TICKER Europe U.S.A. Bloomberg: ECX:GR Antje Zeise Lauren Kwiecinski Reuters: EXXG.DE Manager Investor Relations Senior Associate Thomson ONE: ECX-XE Epigenomics AG The Trout Group LLC T. +49 30 24345 0 T. +1 646 378 2934 ADR OTC: EPGNY ir@epi