Slide 1: Liquid Biopsy Cancer Screening and Detection
Liquid Biopsy Cancer Screening and Detection Company Presentation
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT Forward Looking Statements This communication contains certain forward-looking Such factors include, among others, the following: statements, including, without limitation, statements uncertainties related to results of our clinical trials, the containing the words “expects”, “
Slide 3: Management Team Presenters
MANAGEMENT TEAM PRESENTERS Chief Executive Officer President and Chief Greg Hamilton has over 20 years Scientific Officer of management experience Jorge Garces has over 20 years in molecular diagnostics, of management experience in manufacturing and professional the life sciences industry. service i
Slide 4: First FDA Approved Blood-Based Colorectal Cancer Screening Test
FIRST FDA APPROVED BLOOD-BASED COLORECTAL CANCER SCREENINGTEST Epi proColon® is indicated for colorectal cancer screening: - in average-risk patients 50 – 75 years old - patients who were offered and declined colonoscopy and stool-based fecal immunochemical tests (FIT) FDA APPROVED PMA LIQUID BIOPSY
Slide 5: CRC Market Overview
CRC MARKET OVERVIEW Other 1M Stagnant screening rate GOAL GAP Unscreened 32M over the past years 60% 63% 65% 62% 80% 2006 2008 2012 2017 2018 Age-Eligible New CRC Deaths Screening Population Cases Colonoscopy 39M Unscreened 32M 43% 70% Screened 53M Cologuard <1.7M FIT/FOBT 11M 57% 30% ACS guideline
Slide 6: Key Reimbursement Coverage Milestones
KEY REIMBURSEMENT COVERAGE MILESTONES Medicare Coverage 2016 FDA-Approval 2019 CMS sets final Price => $192 Feb 28, 2020 NCD “opened” Aug 28, 2020 Proposed Decision Memo Nov 28, 2020 Final Decision Memo LIQUID BIOPSY CANCER SCREENING AND DETECTION 6
Slide 7: Medicare National Coverage Determination Process
MEDICARE NATIONAL COVERAGE DETERMINATION PROCESS Preliminary Discussions Reconsideration Benefit Category 6 Months 30 days 60 days Final Decision National Coverage National Coverage External Technology Proposed Decision Memorandum and Request Staff Review Staff Review Request Accepted Assessment Mem
Slide 8: CMS Decision Criteria
CMS DECISION CRITERIA Reasonable Necessary • Food and Drug Administration (FDAApproved) • An estimated nine million Medicare beneficiaries are not up - Safe and Effective to date with CRC screening - Approximately one out of every three eligible adults 65 years • Clinical Utility of age (YOA) and ol
Slide 9: Key Rationale for Medicare Coverage
KEY RATIONALE FOR MEDICARE COVERAGE FDA Approved (PMA) Test Published peer-reviewed microsimulation data on long-term benefits, harms, and testing interval Overwhelmingly positive public support Inclusion in 2020 National Comprehensive Cancer Network (NCCN) CRC Screening Guidelines Cost Effective LI
Slide 10: Non-Invasive CRC Screening
NON-INVASIVE CRC SCREENING Non-Invasive Screening Methods in Comparison to “No Screening” and Colonoscopy Unscreened CRC Cases FIT/DNA (3-yr) Epi proColon (1-yr) FIT (1-yr) Colonoscopy (10-yr) Unscreened CRC Deaths FIT/DNA (3-yr) Epi proColon (1-yr) FIT (1-yr) Colonoscopy (10-yr) D’Andrea E, Ahnen D
Slide 11: Non-Invasive CRC Screening: Reported Adherence
NON-INVASIVE CRC SCREENING REPORTED ADHERENCE Non-Invasive Screening Methods in Comparison to “No Screening” and Colonoscopy Unscreened CRC Cases FIT/DNA (3-yr) Epi proColon (1-yr) FIT (1-yr) Colonoscopy (10-yr) Unscreened CRC Deaths FIT/DNA (3-yr) Epi proColon (1-yr) FIT (1-yr) Colonoscopy (10-yr)
Slide 12: Yearly Interval Is Best Choice for SEPT9 Screening
YEARLY INTERVAL IS BEST CHOICE FOR SEPT9SCREENING Lifetime number of colonoscopies and life-years gained (LYG) The efficiency ratio (ER) provides a measure by SEPT9 screening interval of the benefits from screening (LYG) along with the burden of testing (COL) required 325 to achieve those gains and
Slide 13: Associated Harms
ASSOCIATED HARMS Number of Tests per 1000 Screened: Number of Tests per 1000 Screened: Full (100%) Adherence Reported Adherence Non-Colonoscopy Tests Colonoscopies Sept9 (1Yr) Colonoscopies Total Colonoscopies 10Y Non-Colonoscopy Tests Colonoscopies Sept9 (1Yr) Colonoscopies Total Colonoscopies 10Y
Slide 14: NCCN – Guideline Inclusion
NCCN – GUIDELINE INCLUSION The new 2020 NCCN guidelines state that although the mSEPT9 blood test is “not recommended for routine screening”, it however “can be considered for patients who refuse other screening modalities” • Consistent with Epi proColon’s (Septin9) FDA-approved indications: - The E
Slide 15: How Screening Saves Medicare Money
HOW SCREENING SAVES MEDICARE MONEY • 1 of 3 eligible Individuals are not screened NCI-Sponsored Cost Model 1 NCI-Sponsored Cost Model 2 • Over 30 million Americans are not up to MISCAN ($) SimCRC ($) date with CRC screening 2010 2020 2030 2040 2050 2060 2010 2020 2030 2040 2050 2060 • These folks ac
Slide 16: Medicare Reimbursement Key Milestone
MEDICARE REIMBURSEMENT KEY MILESTONE Rate Coverage • $192 • National Coverage • CPT Code 81327 Decision (NCD) • Legislation LIQUID BIOPSY CANCER SCREENING AND DETECTION 16
Slide 17: High Value Screening Test
HIGH VALUE SCREENING TEST Epi proColon® $192 CT/NG $70.18 HCV $42.84 HIV $85.10 HPV $35.09 0 $50 $100 $150 $200 Clinical Lab Fee Schedule 2018 CMS.gov. 2018 Preliminary Gapfill rates 2018 CMS.gov LIQUID BIOPSY CANCER SCREENING AND DETECTION 17
Slide 18: Epi proColon Revenue Stream Impact
EPI PROCOLON REVENUE STREAM IMPACT Epi proColon Doctor: Patient $192 Revenue for Interaction BLOOD SAMPLE Physician Health REPORT Doctor & Blood Drawn System Lab or Reference Lab Direct CLIA Model Bypass Physician Interaction SAMPLE COLLECTION KIT Kit and Performs STOOL SAMPLE Health System REPORT D
Slide 19: Competition/Future Potential: Tests in 5-6 Years
COMPETITION/FUTURE POTENTIAL TESTS IN 5-6 YEARS Non-Invasive Screening Methods in Comparison to “No Screening” andColonoscopy Unscreened FIT/DNA (3-yr) CRC Cases Epi proColon (1-yr) FIT (1-yr) Colonoscopy (10-yr) 90/90 Test (3-yr) 90/90 Test (2-yr) 90/90 Test (1-yr) Unscreened FIT/DNA (3-yr) CRC Dea
Slide 20: Competition/Future Potential Test Harms
COMPETITION/FUTURE POTENTIAL TEST HARMS Harms Total Cost (Millions) # Tests # Colonoscopies Septin9 1Yr Septin9 1Yr 90/90 3 Yr 90/90 3 Yr 90/90 2 Yr 90/90 2 Yr 90/90 1 Yr 90/90 1 Yr Colonoscopy 10y Colonoscopy 10y 0 1k 2k 3k 4k 5k 6k 7k 8k 9k 10k 0 $2 $4 $6 $8 $10 $12 LIQUID BIOPSY CANCER SCREENING
Slide 21: Product Pipeline
PRODUCT PIPELINE CRC EPC: 45 – 49 year-old Liver Cancer: FDA approval • >$3B market opportunity • FDA “roadmap” via Cologuard • ~ 3 years to FDA approval ~1,000 patients Specificity in an average risk 45 – 49 age group • Opportunity 20M patients >$3.5B per year market NEXT STEPS 1. Upon reimbursemen
Slide 22: Financial Overview
FINANCIAL OVERVIEW Q1-2020 Financial Highlights EURm Q1-2020 Q1-2019 Variance REVENUE 0.2 0.3 (0.1) ADJ. EBITDA* (2.7) (3.0) 0.3 Net result (3.0) (3.0) 0.0 Cash consumption (3.3) 4.3 1.0 Liquid Assets ** 11.0 2020 Financial Outlook Revenue EBITDA* Cash Burn EUR 1 to 2M EUR -10.5m EUR -10.5m to -12.5
Slide 23: Share Information
SHARE INFORMATION ISIN DE000A11QW50 Shareholders Segment Prime Standard, FSE Deutsche Balaton AG 16.22% IPO 2004 Bridger Healthcare Ltd. 9.66% Total Shares 47.1 Million Altium 5.19% Freefloat 64% 683 Capital 5.16% Coverage Warburg Research Pareto Securities AS First Berlin Equity Research Ticker Enc