Multi-Modal BioInformatics Solution for Ovarian Cancer Valerie Palmieri, President and CEO NASDAQ: VRML l December 2019 - Aspira Labs
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Multi-Modal BioInformatics
Solution for Ovarian Cancer
Valerie Palmieri, President and CEO
NASDAQ: VRML l December 2019
©2019 Vermillion Inc. All Rights Reserved
Safe Harbor
This presentation contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Words such as “may,”
“expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar
expressions are intendedto identify such forward-looking statements.
Readers are cautioned that these forward-looking statements speak only as of the date of this presentation, and the Company does not assume any
obligation to update, amend or clarify them to reflect events, new information or circumstances after such date except as required by law. Company
estimates set forth in this presentation are based on various sources of information and various assumptions and judgments made by the Company,
which Company management believes are reasonable. However, the Company cannot assure you that Company estimates are correct, and actual data
may materially differ from Companyestimates.
The forward-looking statements reflect the views of the Company as of the date of this presentation and are subject to certain risks, uncertainties and
assumptions, including those described in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2018 and quarterly report on Form 10-Q for the quarter ended September 30,2019.
This presentation is © copyright 2019 by Vermillion, Inc. All RightsReserved.
2
Our Mission
Enable Early
Ovarian
Cancer
Detection for
All Ages and
Ethnicities
3
Investment Highlights
Commercial stage company with FDA-cleared multi-modal disease management
approach to women’s health, with core focus on ovarian cancer
FDA-cleared 2nd-generation technology; included in clinical treatment guidelines
Appropriate commercialization strategy addressing sizable potential markets
Compelling pipeline of diagnostic bioinformatic product candidates
Strong intellectual property protecting methods and use
Broad managed care coverage: 2018 CLFS* reimbursement rate of $897
Experienced management team
4
*US - Clinical Laboratory Fee Schedule 4
Vermillion’s Evolution
Save Lives &
Replace Standard of Care
Expand Commercial
Infrastructure (2019)
2nd Generation
OVA1 Plus foundation in place
Completed OVA1 Plus Launch (Q4’18) to become
NEW Standard of Care
Payers (2018-2019)
Guidelines (2016-2018) Payer Coverage:
5 out of 10 lives
Bioinformatic Tools + Current Standard of Care (2016)
covered in U.S.
Strong IP and FDA-Cleared Science (2010-2018)
5
The Size of the Pelvic Pain and Mass Market
Technology VRML
TAM Cost $ Today Portfolio
Pelvic Masses +
18.3M $22B (Endo + PCOS+ Func. Cysts)
POC Complete
None (DXA II) (2021)
500K- Pelvic Masses 2-4 X/yr Watch + Wait
1M (Benign masses, cancer, non-gyn mass) CA125/none (DXA1) (2020)
$0.8B
300- 2X/yr
High Risk BRCA Monitoring Portfolio
500K
CA125 Expansion
200K Pelvic Masses to Ova1+ Ova1+
Surgery (OVA1, Overa) (OVA1, Overa)
22K $5.2B CA125
Ovarian Cancer Portfolio
Recurrence
Monitoring Expansion
Ovarian
15K Cancer
Deaths
Total: 20M $28B
6
6
Paradigm Shift: Single- vs. Multi-modality Approach
Protein Biomarkers Clinical Assessment +
OVA 360
(Systemic Dx) Imaging
(Focused Dx) - Systemic Dx
=
- Focused Dx (TVUS)
Q4 2018 OVA360 Q4 2018
- Family Hx /
Genetics
Hereditary Breast and
Ovarian Cancer (HBOC) Patient Reported Data
(Family Hx) Genetics (Symptom Index) - Patient Reported
2H 2019 2H 2019 Data (Symptom
Index)
7
7
Ovarian Cancer: Severe Clinical Problem
Presentation Stage and 5-Year Survival Rate(1)
Presentation Stage Incidence Five Year Survival Rate
(Stage I) Localized 15% 92%
(Stage II) Regional 21% 75%
(Stage III) Distant 59% 29%
(Stage IV) Unstaged 6% 24%
Clinical Need for a Diagnostic Solution with Adequate Predictive Value to:
Ensure earlier cancer detection
Accurately identify patients needing timely treatments from gynecologic oncologists
(1) www.SEER.Cancer.gov.
8
Root Causes for Delayed & Non-Actionable Diagnoses
Category Clinical Assessment Blood Tumor Marker Tissue Analysis
Tools § Physical exam & § CA-125 (off-label) § Pre-operative
ultrasound § ROMA™ (alternative) biopsy
Limitations § Subjective results § Low sensitivity § Biopsy rupture
due to specialists’ § High false negatives, risks (potential
interpretation (pre-menopausal / tumor spread)
early-stage)
9
Current Care Pathway
Level A guideline for pelvic mass assessment results in ~70% unclear results and leads to ineffective care pathway
Level A Guideline
Pelvic Mass Transvaginal
Ultrasound (TVUS) Assessment
(0.5M – 1M Patients)(1) Clearly
Clearly Malignant
Benign (27%) Level B (3%)
Unclear Results (CA-125)
~70% of Cases(1)
CA-125 &
Watchful Waiting /
(~400K Patients) Immediate Referral to
Management of
Gynecological
Symptoms
Oncologist
Ineffective Care Pathway Results:
§ Late-stage detection (65%)(2)
§ Gynecological oncologist referral delay (40%)(4)
§ High cost with no improvement in clinical outcomes ($5B(3) of U.S.
annual costs with 52+% mortality(2))
(1) Based on management estimates and analysis.
(2) www.SEER.Cancer.gov.
(3) Estimates from Projections of the Cost of Cancer Care in the United States:2010–2020, J Natl Cancer Inst 2011;103:117–128.
(4) Racial Disparities in the Receipt of Guideline Care and Cancer Deaths for Women with Ovarian Cancer Cronin Et al 2018 Nov Cancer 10
Epi Prev Biom.Our Solution = OVA1® + OVERA® (OVA1 +)
• OVA1 evaluates the levels of five ovarian
cancer-associated markers in the blood
• Levels combined into single cancer risk score.
Multi-variate Index Assay (MIA) in ACOG Guidelines
Positive NCCN and SGO position statements
• Overa incorporates 2 new markers
• Global Platform
• Specificity +
11
11Improved Specificity :
OVA1 Plus - Ova1/Overa Reflex Offering (Q4 2018)
Low Risk
Intermediate Risk Reflex to:
ACOG Endorsed
Elevated Risk
ACOG Endorsed
OVA11 Overa1 OVA1 + % Diff
Premenopausal2: Low Risk < 5.0; Intermediate
(95%CI) (95% CI) (95% CI) OVA1 vs OVA1+
5.0-7.0;
Elevated Risk > 7.0 Sensitivity 92% 91% 88% -4%
Postmenopausal2: Low Risk < 4.4; Intermediate
4.4-6.0; Specificity 54% 69% 72% 33%
Elevated Risk > 6.5
> 30% improvement in specificity
1. Coleman RL, Herzog TJ, Chan DW, et al. Validation of a second-generation multivariate index assay for malignancy risk of
adnexal masses. Am J Obstet Gynecol 2016;215:82.e1-11. 12
2. Reference Ranges established by ASPiRA Labs, Austin Tx. 12How is this Care Pathway Different?
Level A (TVUS) and Level B ACOG (OVA1)
Refer
Gyn Onc
ACOG ACOG Elevated Risk
Level A Level B of Malignancy Gyn Onc
Consult
~70% of
PELVIC Cases CU study
PELVIC
MASS Ensure
Everything else results
MASS
TVUS ON Proper 100%
(3-10cm) not thin
0.5-U/S
1.0M walled, >1
Triage Proper Triage
septation, small 99% NPV**
nodules* Lower Risk of No Need
Malignancy to Refer/Surgery by
False Negative Gyn
Rate < 10%
No Further Imaging
• This does NOT include other risk factors for ovarian cancer such as family history or Hereditary Cancer Syndromes
• ** ACOG Nov 2016 citation
13
13Improved Early Stage Detection:
OVA1 Plus vs Standard of Care (Stage I + II)
94% Improvement in Rate of Cancer Missed with OVA1
14
14Early Detection Lowers Total Healthcare Costs
93K Medical Claims Study Demonstrated that the Use of OVA1 Plus Compared to CA-125 II
Can Lower Total Costs While Improving Care
Cost Comparison of Early vs. Late Stage Detection(1,2)
84% Decrease in Cost Burden
Pre-
§Total ovarian Menopausal
cancer-related $224,922
Post-
costs = $5B $197,757 Menopausal
total U.S. and
$46.4B total 81% Decrease in
global(3) Cost Burden
$35,754 $37,195
Late Stage Early-Stage
(1) 24-Month Average Reimbursement for Early and Late Stage Cancer.
(2) Brodsky B.S., Owens G.M., Scotti, D.J., et al. AHDB. 2017:10(7):351-359.
(3) Lindsey A. Torre, Farhad Islami, Rebecca L. Siegel, Elizabeth M. Ward and Ahmedin Jemal. Cancer Epidemiol Biomarkers Prev April 1 2017 (26) (4)
444-457; DOI: 10.1158/1055-9965.EPI-16-0858; WHO fact sheet.
15Race Based Disparity in CA125 Values - 2001-2017
This disparity is found in healthy women, women at high risk for ovarian cancer, and women with
ovarian cancer(1-4)
CA125 (%, Caucasian Value is 100%)
Skates et al. 2011
Babic et al. 2017 Cramer et al. 2010 Pauler et al. 2001 (Post-menopausal) (Pre-menopausal)
100
75
Caucasian
Non-
50
Caucasian
or African
American
25
0
Studies include =~ 600-18,000 patients
(1) Pauler, D., et al. Factors Influencing Serum CA125II Levels in Healthy Postmenopausal Women. Cancer Epidemiology, Biomarkers & Prevention, 10: 489-493, 2001.
(2) Skates, S., at al. Large Prospective Study of Ovarian Cancer Screening in High-risk Women: CA125 Cut-point Defined by Menopausal Status. Cancer Prevention Research, 4(9), 1401–1408, 2011. 16
(3) Cramer, D., et al. Correlates of the pre-operative level of CA125 at presentation of ovarian cancer. Gynecologic Oncology, 119(3), 462–468, 2010.
(4) Babic, A., at al. Predictors of pretreatment CA125 at ovarian cancer diagnosis: a pooled analysis in the Ovarian Cancer Association Consortium. Cancer Causes & Control : CCC, 28(5), 459–468, 2017.OVA1® Superiority over CA125 in African American Women
Positive Negative
Predictive Predictive
Sensitivity (%) Specificity (%) Value Value
Caucasian (N=868) 93.2 45.3 40.8 94.3
OVA1®
African American (N=156) 79.2 66.7 30.2 94.6
Caucasian (N=868) 74.4 87.6 70.7 89.5
CA125
African American (N=156) 33.3 94.0 50.0 88.6
§ CA125 has an unacceptable sensitivity for cancer detection in African American women
§ Abstract accepted at American Association for Cancer Research (AACR)
§ Aug and Sept 2019 - 2 peer reviewed publications
§ OVA1® shows acceptable sensitivity for cancer detection in African American women, cutoff adjustment is in
process for pre- and post-menopausal women, to achieve 90% sensitivity obtained for Caucasian women1
1 ASPiRA Labs Data on File, Combined OVA1 and OVA500 studies.
17OVA1 Plus Improves Early Stage Detection
Comparison of CA-125 II vs. OVA1+
Sensitivity Across All Ovarian Cancer Stages(1) CA-125 II
Stage I X ✓
Stage II X ✓
Stage III ✓ ✓
Stage IV ✓ ✓
Sensitivity Across Menopausal Status(1)
Pre-menopausal X ✓
Post-menopausal ✓ ✓
Sensitivity Across Histological Subtypes(1)
Epithelial ovarian cancer ✓ ✓
Non-epithelial cancer X ✓
Low malignant potential X ✓
Metastatic ✓ ✓
Other gyn cancer X ✓
Sensitivity Across All Ethnicities(2)
Caucasian and African American X ✓
(1) Longoria T.C. et al. Am J Obstet Gynecol 2014;210:78 e1-9.
(2) From company’s 2019 AACR Abstract 1244, “Ethnic disparity in ovarian malignancy tumor markers: MIA and ROMA.” 18Large and Growing Total Addressable Market
Long-Term
Addressable Markets
Near-Term
Addressable Markets Endo + PCOS+ Func.
Benign Masses, Non- Cysts Detection:
Ovarian Cancer, Non-Gyn
Mass Monitoring: § ~17M U.S. patients
Currently § No current solution available /
§ ~750K to 1M U.S. patients CA-125 used on case by case
Addressable Market basis (off label)
§ Current: CA-125 2-4x/yr
monitoring (off-label) § VRML : POC Complete (2021)
Pelvic Mass Detection:
§ VRML : Watch + Wait (2020)
Ovarian Cancer
§ Surgical triage or guided High Risk BRCA Screening Recurring Monitoring:
referral: ~300-400K U.S. and Monitoring: § ~230K U.S. patients
patients1 § Current: CA-125 2-4x/yr
§ ~300K U.S. patients
monitoring (on-label)
§ ~5% VRML market share § Current: CA-125 2-4x/yr
§ VRML: TBD
§ Current/VRML: Ova1 Plus monitoring (off-label)
§ VRML: (2021)
TAM = 0.3-4 M TAM = ~1-1.3M TAM = ~17M
Total TAM = ~18-20M
Time
(1) Includes surgical; Based on management estimates and analysis.
19Growing Salesforce- Driving Adoption
Marketed directly to gynecologists, gynecology supergroups and healthcare systems
Salesforce Overview
Full-Time Sales Representative Pedigree
§ Completed Two-Phase Salesforce Expansion
o20 full-time (“FTE”) territory sales reps
oTop performers in companies with disruptive technology
20Vermillion Is At a Commercial Inflection Point
Commercial Growth Phase
2.5x commercial investment
Y-o-Y & demonstrated positive
Ob-Gyn reception
Launch of Decentralized
Platform & 2nd Generation/OVA1 Plus
Sales Volume
6 FTEs
Territory
Sales Rep Phase 2 Hiring
Phase 1 Hiring
20 FTEs
SVP Commercial Hired Territory
Evicore Live Sales Rep,
PAMA Rate Total 30 FTEs
21Commercialization Strategy- US + Ex US – Decentralized Testing
• Testing Performed in Hospital Systems/Large Algorithm Warehouse
OvaCalc®
Gyn Super Group
• Increase distribution @ POC (Point of Care)
Cloud based Technology Transfer
• Test performed locally with access to Vermillion risk bioinformatics platform
assessment software via web service
• OVA1 performed on existing Platform Roche Cobas –
installed base of over 10K units globally
Customer Vermillion Data Repository
22International - Commercial Strategy
Both OVA1/Overa have CE Mark Philippines
• Large prospective study in process
Israel
• Q4 2018 – Coverage received in Israel by CLALIT
• 2nd largest integrated delivery network in the world
• CLALIT (#1 Payer, 50% pop)
• Study in process to validate OVA1 Plus on local
International via population
Platform/Web Service
23Reimbursement and Market Access
Unprecedented reimbursement success
Coverage: Patient Lives In Millions Weighted Average OVA1 Price Per Test
167M Target Goal
Oklahoma
Tennessee PAMA(1) Price
New Mexico $897
Arizona
120M
Texas Montana
$333 $361 $345
Illinois $254
100M
$236
CareFirst $125
Louisiana
80M Arkansas
Michigan
Goal: Targeted Growth with Positive
Novitas Medical Policy Decisions
2014 2015 2016 2017 2018 YTD 2019
§ Cigna added OVA1 to its national preferred coverage § OVA1 PAMA price set for 2020 – 2022 = $897
list in January 2019
§ CPT code 81503
§ 51% of the population now under positive coverage
(1) Protecting Access to Medicare Act of 2014 (PAMA).
24Current Financial Priorities
Margin Expansion
25Catalysts Driven Momentum Through 2020
Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 1H 2020 2H 2020
Increased Market Access via Cigna
CA-125II Disparity § Q1 2019, Cigna added OVA1 to its national Increased
Validation preferred coverage list Adoption of Expanded Bio-
§ Q4 2018, presented § 15 M lives added (167M total number covered OVA1 plus + informatics
CA125 disparity data at lives as of Q1 2019) Genetix Platform- Beyond
the Mid-Atlantic Proteins
Gynecologic Oncology Expanding Sales Team
Society Decentralized
§ Phase 2 hiring completed in Q1 2019 (11 FTE)
Partnership
Expansion
Hereditary Breast and Ovarian Cancer
Expanding Sales Team (HBOC) Genetics (June 2019)
§ Phase 1 hiring completed
in Q3 2018 (9 FTE)
Clinical Assessment & Imaging+
Symptom Index (Q3 2019)
Watch and Wait Portfolio Expansion (2020)
Payer Expansion Pelvic Mass Portfolio Expansion OVA 360
§ Systemic Dx
Data Repository § Focused Dx (TVUS)
with Bioinformatics § Family Hx / Genetics
Platform § Patient Reported Data
(Symptom Index)
26Compelling Growth Strategies
Expand
Distribution
Platform
Beyond the U.S. by
launching OVA1 Plus
Enterprise Value
while building the clinical
Expand Product utility and health
Offerings economics foundation
Offer pelvic disease
Become the diagnostic and
prognostic solutions
Standard of Care
from puberty to cure
for Global Pelvic from endometriosis
Leverage the Mass Risk and ovarian cancer
Largest Specimen Assessment
and Data
Repository
Of gynecologic pelvic
mass patients worldwide
27Investment Highlights
Commercial stage company with FDA-cleared multi-modal disease management
approach to women’s health, with core focus on ovarian cancer
FDA-cleared 2nd-generation technology; included in clinical treatment guidelines
Appropriate commercialization strategy addressing sizable potential markets
Compelling pipeline of diagnostic bioinformatic product candidates
Strong intellectual property protecting methods and use
Broad managed care coverage: 2018 CLFS* reimbursement rate of $897
Experienced management team
28
*Clinical Laboratory Fee ScheduleAppendix
Trusted Solution: Care Pathway Guidelines
Published Evidence OVAI (MIA) Guidelines / Position Statements(1)
Ueland, et al Obstetrics and Gynecology, 2011
ACOG Practice Bulletin
Gynecologic Oncology, 2013 Am J Gynecol,
Bristow, et al. Number 174, November 2016, page 10
2013
Longoria, et al. Am J Obstet Gynecol, 2013
Goodrich, et al. Am J Obstet Gynecol, 2015 National Comprehensive Cancer Network
Guidelines, Version 5, 2017
Forde, et al. Curr Med Res Opin, 2015 Updated Feb 2, 2018
Coleman, et al. Am J Obstet Gynecol, 2016
Eskander, et al. Am J Obstet Gynecol, 2016 Society of Gynecologic Oncology Position
Statements Issued 2011 Updated 2013
Int. J Gynecol Cancer, 2017, Gynecologic
Urban, et al.
Oncology, 2018
Brodsky, et al. Am Health & Drug Benefits, 2017
Shulman, et al. Advances in Therapy, 2019 (1)In 100% of all Key Guidelines
Fredericks, et al. Journal of Surgical Oncol, 2019
Biomarkers in Cancer, 2019, Future Oncology,
Dunton, et al.
2019
Zhang, et al. Future Oncology, 2019
30Protected Solutions: Strong IP
Granted Pending (Approx.) Family
USA Ex US Total USA Ex US Total
20 65 85 9 31 40 24
Issued patents covering various Pending patent applications Algorithm –
ovarian cancer biomarkers including OVA1 and kept as trade secret
Overa products
31Majority of Pelvic Masses Are Benign
A low false negative rate is critical for patient care
Early Stage Sensitivity Early Stage False False Positive
(%) Specificity (%) Negative Rate (%) Rate (%)
Clinical Assessment (CA)(1) 68.6 86.3 31.4 13.7
Ultrasound alone(2) 41.2(9) 74.7 58.8 25.3
Standalone Risk Stratification
CA125 alone(1) 62.8 89.6 37.2 10.4
ROMA (Ca125 & HE4)(3-4) 63.6 86 36.4 16
OVA1® alone(5) 91.4 53.5 8.6 46.5
Overa® alone(6) 88.6 69.1 11.4 30.9
OVA1 Plus(7,8) 86.8 72 13.2 28
1. Longoria, TC et al. AJOG Jan 2014, 210(1,): 78.e1-78.e9 Demonstration of
2. Pavlik EJ, van Nagell JR Jr. Womens Health (Lond). 2013 Jan;9(1):39-55
3. Partheen K, Kristjansdottir B, Sundfeldt K. J Gynecol Oncol. 2011;22(4):244-52. Improvement - Reducing False
4. Chudecka-Glaz, A et al. J Mol Biomark Diagn. 2013, S4:003
5.
6.
Bristow, RE et al. Gynecol Cncol. 2013, 128:252-259
Coleman RL, Herzog TJ, Chan DW, et al. Am J Obstet Gynecol 2016;215:82.e1-11.
Negatives by Over 50%
7. ASPiRA Labs Data on File, Combined OVA1 and OVA500 studies.
8. Internal data on file.
9. Average of 4 trials in study.
32OVA360 Disease Management
Vermillion enables multi-modality approach to disease management
OVA360 Disease Management
Focused
FDA- Diagnostics
(MRI,
§ Vermillion is the first company to Cleared
Ultrasound)
develop FDA-cleared blood based Algorithms
360
detection algorithm
§ In current disease management
schema, adjacent technology such as
MRI, ultrasound have not been Patient
incorporated into patient’s treatment Genetics Reported
plan Panels Data
(Hx,
§ Vermillion has collected a large volume Symptoms)
of data to create FDA-cleared
algorithms (proteins only) and in future
the vision is to combine multi-modalities
Systemic
Diagnostics ctDNA
(Blood,
Exosomes Subjective Modality
proteins)
Objective Modality
Future Modality
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