Post on 21-Jan-2018
transcript
Easy, Accurate & Affordable Colorectal Cancer Screening
presented by:
Donald F. Weber, CEOweberd@beaconbiomedical.com
ColoRT™
Problem
EEEW!
YIKES!
Solution – ColoRT™
Traditional ELISA-Test
Point-Of-Care Test
ColoRT™
.
Technology
� Leveraging Decades of Research, Millions of Dollars and 24-Issued Patents
� Capital Efficient Business Model with Sustainable Market Advantage
� Dramatically Reduce Time & Cost to Market
1.625”
Patented Oncoprotein
Cripto-1Patented Device
Rapid Vertical Flow
Technology Validation
CRC
A.
Beacon-NIH Grant Validation
Viable
25-47%
Viable
75-92%
Viable
78-95%
Replication & Benchmark Study (60-90 Days)
91
57
99
CRC TestsCRC
Accuracy<90%
AA Sensitivity
46% <
Cost ($)<100
Sample Type
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Competitive Advantage
Offered
Colonoscopy
36% Colonoscopy
64%Refused
Colonoscopy
83%Took
Blood Test
15%
Took Fecal Test
2% Refused
Offered Alternative
Patient Preference
For Patients
• Most convenient
• Preferred sample
For Doctors
• Save lives through improved screening
• Reduces time / expense of follow-up
• Provides a revenue stream
For Payers
• Reduces systemic cost of cancer treatment
• Most cost effective solution
Stakeholder Benefits
“If ColoRT test can replace the use of an FIT for
screening my patients for advanced adenomas and
colorectal cancer, I would use it in a heartbeat.”
- Dr. Vafa Matin, Internist, CareMD
Stakeholder Testimonials
“My buddies and I have been talking about getting
screened for months, but we’re all dragging our feet.
If your test was available, I’d take it.”
- Eric M., Patient
“If Cripto-1 can detect advanced adenomas with decent
sensitivity, this is a game changer”
- Dr. R. Pamukcu, Gastroenterologist
CEO Midway Pharmaceuticals
ColoRT™ - CRC & Advanced Adenoma Screening
US:
• $1.2B, 24MM Patients, Noncompliant
• $3.5B, 69MM Individuals, Full Screen
EU:
• $4.0B, 114MM Patients, Full Screen
Future Cancer Screening
• Breast
• Lung
• Prostate, Ovarian, Pancreatic
Market
Intellectual Property:
• 24 – Issued Patents (Device & Chemistry)• World-wide Coverage• Addition of Future IP (Devices & Chemistries)
Regulatory:
• US - LDT > FDA 510(k) DeNovo, CLIA Waiver• EU - CE Mark
Reimbursement:
• Cash Pay > Private Payer > CMS• Both ELISA and POC Tests
Regulatory, Reimbursement & IP
Strategics
Time
FinancialMilestones $800M
(Seed / Grants)
1) ColoRT LDT
2) FDA Pre-sub
3) Device Prototype
M&A
$5.0M(Series B)
1) ColoRT EU
2) ColoRT US
3) BreastRT Test DevPortfolio
Milestones
Milestones / Timelines
2016 2017 2018 2019 2020
$3.0M(Series A)
1) ColoRT Clinical Study
2) Strategic Partnering
Financial Projections
Beacon Biomedical 2016 2017 2018 2019 2020
Number of Units Sold 3,000 67,000 701,000 2,220,000 3,893,000
Avg. selling price $25 $25 $32 $36 $37
Gross margin % 83% 83% 88% 88% 89%
Below in ($1,000s)
Revenues 580 2,331 23,163 80,183 146,703
Total Op Expenses $1,158 $5,283 $25,995 $58,441 $91,701
EBITDA -578 -2,952 -2,832 21,743 55,002
Cash Flow ($578) ($2,952) ($2,832) $15,872 $40,152
Product Drivers LDTs (CRC, BC) CRC Kits / POC BC POC
Milestone – Valuation Benchmarks
EXAS
$900 MM
VolitionRx
$79 MM
Beacon Biomedical
CE Mark, FDALDT, CE MarkEarly Stage
Epigenomics AG
$38 MM
Ma
rket C
ap
Team
● Donald F. WeberCEO & President
● F. Randall GrimesCOO
● Andreas Jeromin, Ph.D.CSO/PI
Advisors
● Dr. Adeyinka Laiyemo, MDHoward University.
● Dr. Robert Bowser, MDDignity Health/IronHorse Dx
● Dr. Kevin Jones, PhDMedMira, Inc.
● Mr. Dirk K. BethHyalescent Ventures
Use of AIC Proceeds
Q&
A
Donald Weber, CEOweberd@beaconbiomedical.com
ColoRT™
Specificity vs. Other Cancers
Recent Example:
Cologuard PMA Showed Positives for other Cancers
Non-Issue for FDA in PMA Review
Disease or Cancer
Specimens
Tested
Incident Rate per
10,000
% Positive
Coloquard
Hepatic Cancer 6 0.8 50%
Pancreas Cancer 12 1.2 41.6%
IBD 18 1 38.9%
Gynecological Cancer 11 2 36.4%
Rheumatoid Arthritis 15 4.1 26.7%
Stomach Cancer 8 0.8 25%
Lung Cancer 10 6.5 20%
Esophagus Cancer 11 0.5 18.2%
Bladder Cancer 17 2.3 17.6%
Cost Parity w/ FIT $91.19/Test*
Cost Parity w/ Cologuard $288.75/Test*
*Price point/test at which screening individuals with Beacon’s CRC Test would yield a cost/QALY on par with that of FIT and Cologuard for colorectal cancer (CRC ) cases detected w/ advance adenomas (AA), respectively.
$US
Reimbursement Economics
Clinical Trial Size
* Source: Epigenomics
Downstream Value Analysis
Value Chain Amount
A
Amount
B
Amount
CNotes
MSR Selling Price* $50 $75 $100Doctor’s Retail Charge to
Patient / Insurance
Beacon’s Selling
Price to Doctors*$25 $50 $75 Wholesale Pricing to Doctors
Doctors Profit $25 $25 $25 50% - 100% Gross Margin
COGS $4.25 $4.25 $4.25 83% -91.5% Gross Margin
NIH Licensing $1.25 $2.50 $3.75 NIH CR-1 license
MedMira
Licensing$1.00 $2.00 $3.00 Estimated at 4% of sales
Distribution $7.50 $7.50 $7.50 Estimated $7.50/unit
Total Costs $14.00 $16.25 $18.50 Exclusive of indirect costs
Beacon’s Net Profit $11.00 $33.75 $56.50 44% - 75.3% Net Margin
* Initial cost/benefit pricing parity analysis indicates a $54-$110 range to consumer could be potentially reimbursed. As such, prior
to product launch an adoption- pricing optimization assessment will be completed to insure Beacon is not under pricing its
wholesale cost to physicians/buyers.
24
US FDA Regulatory Pathway
Strategics
Industry Collaborators
MedMira POC Devices OEM
Mfg
Abcam Antibodies / Kit Mfg
IronHorse Dx /
Dignity Health
Assay Development
& LDT Launch
IHT Cancer POC Clinics
Academics / Institutions
Nat’l Inst. of Health. SBIR Grant
Award
Howard University SBIR
Collaborator
Boston University Grant
Collaborator
Advocates
Colon Cancer Alliance
EmpowHER
Hologic
Potential Licensees
A – Multi Nat’l Dx
B– Multi Nat’l Rx / Dx
C– Multi Nat’l Dx / Women’s
Health