Epigenomics AG · GETTEX:ECX
Epigenomics — Q2 2016 Earnings Presentation
19 slides from Epigenomics's earnings presentation, Aug 10, 2016
Slide 1: Investor Conference Call on Q2/2016 Financial Results
Investor Conference Call on Q2/2016 Financial Results Greg Hamilton, Chief Executive Officer August 10, 2016
Slide 2: Safe harbor statement
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 risk
Slide 3: Introduction and background – Greg Hamilton
Introduction and background – Greg Hamilton Over 20 years of management experience in molecular diagnostics, manufacturing and professional service industries Chief Executive Officer & Director of AltheaDx, Inc. Chief Operating Officer and Chief Financial Officer of Enigma Diagnostics, Inc.
Slide 4: Strategic priorities for Epigenomics
Strategic priorities for Epigenomics Maximize shareholder value Successful positioning and commercial launch of Epi proColon® - Reimbursement - Key customer target adoption - Medical education (Health Systems, doctors, patients and payors) - Global markets and availability (EU, U.S., China, etc.
Slide 5: Significant milestones of 2nd quarter 2016
Significant milestones of 2nd quarter 2016 FDA LabCorp USPSTF CMS Approval Guideline Meeting Inclusion “Crosswalk” AACR Assay U.S. Trial Poster Verification Sites Initiated Apr May June July/Aug Q2 4 8/15/2016
Slide 6: Q2/2016 Key financials
Q2/2016 Key financials EUR million Q2 2016 Q2 2015 Change in % Revenue 1.3 0.5 +159% EBITDA* (3.5) (2.2) 56% E.P.S. (0.16) (0.15) 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 foll
Slide 7: Liquidity
Liquidity EUR millions June 30, Dec 31, 2016 2015 Liquid assets* 13.2 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 equi
Slide 8: Epi proColon receives FDA approval (April 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 stool- based fecal immunochemical tests (F
Slide 9: Significant portion of population remains unscreened
Significant portion of population remains unscreened Colorectal cancer: One in three Stagnant screening rate in the USA remains unscreened over the past years 80% Screening gap 35% 65% 65% 63% Unscreened 60% eligible population 65% Screened population 2006 2008 2010 2012 2018 About 23 million eligib
Slide 10: Colorectal cancer: Early detection saves lives
Colorectal cancer: Early detection saves lives Diagnosed in Diagnosed in Stage I Stage IV 9 out of 10 survive 1* out of 10 survive 5 years 5 years 9 8/15/2016 Source: American Cancer Society, Cancer Facts & Figures 2015; *rounded (13%)
Slide 11: US commercialization of Epi proColon achieved launch milestone
US commercialization of Epi proColon achieved ever launch milestone FDA approval Apr 2016 “Going Live Package” and other supporting commercialization materials released Initial customer training completed First lots shipped to Polymedco LabCorp “Go-live” => U.S. nation-wide availability
Slide 12: U.S. commercialization with partner
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 Ideally positioned Polymedco is the (colorectal cancer biggest distributor fo
Slide 13: Enabling labs to become part of the colorectal cancer screening solution
Enabling labs to become part of the colorectal cancer screening solution Local Reference medical Labs doctors Leading hospitals Academic Epigenomics Medical Polymedco Centers Key opinion leaders Integrated Healthcare Networks providers As an example of the breadth of Epi proColon’s current sales fra
Slide 14: Reimbursement process underway
Reimbursement process underway National CPT code Coverage HEDIS New Tier-1 Determination Guidelines form code In discussion Inclusion in published in Medical Initiated discussion CMS pricing Guidelines book Health with AHRQ Included in Economics USPSTF Model FDA Label Completed guidelines Granted Ap
Slide 15: USPSTF colorectal cancer screening recommendation
Leena gg Clinical Review & Education US Preventive Services Task Force USPSTF Recommendation Statement: Screening for Colorectal Cancer Figure 2. Screening for Colorectal Cancer: Clinical Summary Population Adults aged 50 t075 y Adults aged 76 to 85 y Screen for colorectal cancer starting at age 50
Slide 16: Blood test for detection of lung cancer
blood test for detection of lung cancer About lung Lung cancer test Performance Target Next steps cancer in development indications Lung cancer is Based on Test sensitivity Follow-up after Clinical studies #1 cancer killer proprietary DNA was reported positive results initiated worldwide m
Slide 17: Revenue and EBITDA outlook 2016
Revenue and EBITDA outlook 2016 Strong revenue increase to EUR 3 to 7m Revenue driven by U.S. launch of Epi proColon® EUR -9.5 to -11.5 million; planned ramp up EBITDA* of U.S. commercial launch and strategic financing alternatives *adjusted for non-cash expenses related to phantom stock programs 16
Slide 18: Q2 highlights
Q2 highlights FDA Approval: Product: Initial lots shipped Nationwide Availability: LabCorp first national reference lab Guidelines: Inclusion in USPSTF Guidelines Reimbursement: CMS Tier 1 Code 17 8/15/2016
Slide 19: Q&A session
Q2/2016 Analyst & Investor Conference Call Q&A session