VERMILLION Multi-Modal BioInformatics Solution for Ovarian Cancer NASDAQ: VRML l August 2019 - Aspira Labs
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VERMILLION
Multi-Modal BioInformatics
Solution for Ovarian Cancer
NASDAQ: VRML l August 2019
©2019 Vermillion Inc. All Rights Reserved
FORWARD-LOOKING STATEMENTS
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, 2017 and quarterly report on Form 10-Q for the quarter ended September 30,2018.
This presentation is © copyright 2019 by Vermillion, Inc. All RightsReserved.
2
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 that is incorporated into clinical treatment
guidelines
Strong commercialization strategy addressing sizable potential markets
Pipeline of compelling diagnostic bioinformatic product candidates
Strong intellectual property protecting methods and use
Broad managed care coverage: 2018 Clinical Laboratory Fee Schedule (“CLFS”)
reimbursement rate of $897
Seasoned management team
3
3
Vermillion’s Evolution
Save Lives &
Replace Standard of Care
Expand
Q4 2018 Commercial Infrastructure
PQ4 2018 2nd Generation
OVA1 Plus foundation in place
OVA1 Plus Launch to become
P2018-2019 NEW Standard of Care
Payers
P2016-2018 Guidelines Payer Coverage:
5 out of 10 lives
P2016 Bioinformatic Tools + Current Standard of Care
covered in U.S.
P2010-2018 Strong IP and FDA-Cleared Science
4
The Size of the Pelvic Pain and Mass Market
Technology
TAM Cost $ Solutions VRML
Pelvic Masses + Today Portfolio
18.3M $22B (Endo + PCOS+ Func. Cysts)
None POC Complete
(DXA II) (2021)
500K- Pelvic Masses
2-4 X/yr Watch + Wait
1M (Benign masses, cancer, non-gyn mass)
$0.8B None (DXA1) (2H 19)
300-
High Risk BRCA Monitoring 2X/yr 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
5
5
Paradigm Shift- Single Modality vs. Multi-modality Approach
Protein Biomarkers Additional Tech
OVA 360
- Systemic Dx
Q4 2018 TBD
=
- Focused Dx (TVUS)
OVA360
- Family Hx /
2H 2019 2H 2019 Genetics
Hereditary Breast
Clinical Assessment and Ovarian
& Imaging+ Cancer (HBOC) - Patient Reported
Symptom Index Genetics Data (Symptom
Index)
6
6
Our Mission
Enable Early
Ovarian
Cancer
Detection for
All Ages and
Ethnicities
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 biopsy
ultrasound § ROMA™
(alternative)
Limitations § Subjective results § Low sensitivity § Biopsy rupture risks
due to specialists’ (potential tumor
§ High false negative
interpretation spread)
rates, especially in
pre-menopausal and
early stage patients
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 +)
For the detection of Ovarian Cancer Risk in Women with Pelvic Masses
Launch 2010
• OVA1 evaluates the levels of five ovarian
cancer-associated markers in the blood
• Levels combined into a single ovarian
cancer risk score.
Multi-variate Index Assay (MIA) in ACOG Guidelines
Positive NCCN and SGO position statements
Launch
Q4 2018
• Overa incorporates 2 new markers
• Global Platform
• Specificity +
11
11Improved Specificity
OVA1 + - Ova1/Overa Reflex Offering- Launched Q4 2018
Low Risk
Intermediate Risk Reflex to:
ACOG Endorsed
Elevated Risk
ACOG Endorsed
OVA11 Overa1 OVA1 + (95% % Diff
Premenopausal2: Low Risk < 5.0; Intermediate
(95%CI) (95% CI) CI) OVA1 vs OVA1+
5.0-7.0;
Elevated Risk > 7.0 Sensitivity 92% 91% 88% -4%
Postmenopausal2: Low Risk < 4.4; Intermediate 72%
4.4-6.0; Specificity 54% 69% 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)
CLEARLY Get CA-125 and refer to Gyn Onc Immediately
MALIGNANT Refer
(3%) Gyn Onc
Elevated Risk
of Malignancy Gyn Onc
Level A Level B Consult
~70% of
PELVIC Cases
PELVIC
MASS Ensure CU study
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%
CLEARLY
Watchful waiting/management of symptoms No Further Imaging
BENIGN (27%)
• 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 vs Standard of Care in Stage I + II Patients
94% Reduction in Rate of Cancer Missed with OVA1
14
14Early Detection Lowers Total Healthcare Costs
Use of OVA1 Plus compared to CA-125 II can lower total costs while improving care
§ Total ovarian cancer-related costs = $5B total U.S. and $46.4B total global(3)
Cost Comparison of Early vs. Late Stage Detection(1,2)
84% Decrease in Cost Burden
Pre-Menopausal
$224,922
Post-Menopausal
$197,757
81% Decrease in
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.
15Non-White Women, and African-American Women in Particular, Display
Significantly Lower CA125 Values Compared to Caucasian Women- 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
50
25
0
Caucasian Africa Caucasian Africa Caucasian Africa Caucasian Africa Caucasian Africa
American American American American American
or Non- or Non- or Non- or Non- or Non-
White White White White White
1968 (Premenopausal, non-African-American)
3446 (Caucasian) 582 (Caucasian) 17852 (Caucasian) 68 (Premenopausal, African American)
1645 (Non-white) 35 (Non-white) 89 (African-American) 1604 (Postmenopausal, non-African-American)
52 (Postmenopausal, African-American)
(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.
(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.
16High Level Internal Data from ASPiRA LABS®
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 and presented at Mid Atlantic Gynecologic Oncology Society (MAGOS) in October 2018
§ Abstract accepted at American Association for Cancer Research (AACR)
§ Manuscript accepted for publication in Biomarkers in Cancer
§ OVA1® shows an acceptable sensitivity for cancer detection in African American women, cutoff adjustment is in
process for pre and post menopausal women, to achieve the 90% sensitivity obtained for Caucasian women(1)
(1) ASPiRA Labs Data on File, Combined OVA1 and OVA500 studies.
17OVA1 Plus Summary
OVA1 Plus improves early stage detection for all types of ovarian cancer for all ages compared to CA-125 ll
Comparison of CA-125 II vs. OVA1+
Sensitivity Across All Ovarian Cancer Stages(1) CA-125 II • Ovarian cancer remains a diagnostic dilemma for
Stage I X ✓ gynecologists and primary care physicians, making OVA1
Stage II X ✓ Plus clinically relevant
Stage III ✓ ✓
Stage IV ✓ ✓ • For High Risk Patients:
Sensitivity Across Menopausal Status(1)
Early detection and appropriate referral to gynecological
Pre-menopausal X ✓
oncologists give patients survival benefit and proven to be
cost-effective
Post-menopausal ✓ ✓
Sensitivity Across Histological Subtypes(1)
• For Low Risk Patients:
Epithelial ovarian cancer ✓ ✓ The negative predictive value (NPV) of OVA1 Plus will assist
Non-epithelial cancer X ✓ in establishing correct treatment plan, and reassures both
Low malignant potential X ✓ patient and gynecological provider when planning surgery
Metastatic ✓ ✓
Other gyn cancer X ✓ • OVA1 Plus demonstrates improved sensitivity in the African
Sensitivity Across All Ethnicities(2) American population
Caucasian and African American X ✓
OVA1 Plus Changes
(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.”
Patient Treatment 18Large and Growing Total Addressable Market
Long-Term
Addressable Markets
Near-Term Endo + PCOS+ Func. Cysts
Addressable Markets Detection:
§ ~17M U.S. patients
§ No current solution available / CA-
Benign Masses, Non-Ovarian 125 used on case by case basis (off
Cancer, Non-Gyn Mass label)
Monitoring: § VRML portfolio: POC Complete
Currently § ~750K-1M U.S. patients (2021)
Addressable Market § Current solution: CA-125 2-4x/yr
monitoring (off-label) Ovarian Cancer
§ VRML portfolio: Watch + Wait Recurring Monitoring:
(2H 19) § ~230K U.S. patients
§ Current solution: CA-125 2-4x/yr
Pelvic Mass Detection: monitoring (on-label)
High Risk BRCA Screening and
§ Surgical triage or guided referral § VRML portfolio expansion TBD
Monitoring:
(~300-400K U.S. patients, incl.
§ ~300K U.S. patients
surgery and low-risk patients)(1) TAM = ~17M
§ Current solution: CA-125 2-4x/yr
§ ~5% VRML market share monitoring (off-label)
§ Current solution / VRML § VRML portfolio – (2021)
portfolio: Ova1 Plus
TAM = ~1-1.3M
Total TAM = ~18-20M
TAM = 0.3-4 M
Time
19
(1) Based on management estimates and analysis.Growing 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 hired
in total
oAverage ~15 years of experience in genetics,
diagnostic labs and women’s health
oStrong relationships with large Ob-Gyn
practices/physicians in target markets
oTop performers in companies with disruptive
technology
20Vermillion Commercial Momentum
Vermillion is at a commercial inflection point
Commercial Growth Phase
2.5x commercial investment Y-o-Y &
Sales Volume
demonstrated positive Ob-Gyn
3,300 reception
3,129
3,100
Launch of Decentralized
Platform & OVA1 Plus
2,900
2,700
2,500
6 FTEs
Territory Phase 2 Hiring
2,300 2,313
Sales Rep
2,100 Phase 1 Hiring
1,981
1,884 1,996 20 FTEs
1,900 1,818 Territory
SVP Commercial Hired Sales Rep,
Total 30 FTEs
1,700 Evicore Live
PAMA Rate
1,500
Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019
21Two Pronged Commercial Strategy Satisfies
Provider Demand
Test Processed by ASPiRA Labs Test Processed by Providers
§ Test performed locally by providers with access to Vermillion’s risk
§ Samples collected and shipped by providers to ASPiRA assessment software via web service
Labs, Vermillion’s centralized testing platform
o OVA1 performed on locally existing platform (e.g., Roche Cobas – 10K
§ Results shared with providers via portal, fax, etc. installed units WW)
§ Led by experienced team with significant tenure in the o Software subscription revenue model
industry § U.S. – platform targeted towards hospital systems/large gynecology
§ Based in Austin, Texas supergroup
o Increases distribution at Point-of-Care
o Positive policy/coverage facilitates utilization and reimbursement
§ Ex-U.S. – studies in process to validate Overa & OVA1 (CE mark received)
on local high-risk populations, and technology transfer
Algorithm
Technology Warehouse
Transfer OvaCalc®
Customer Vermillion Data Repository
22Reimbursement and Market Access
Unprecedented reimbursement success
Coverage: Patient Lives In Millions Weighted Average OVA1 Price Per Test
Oklahoma
Tennessee Target Goal
New Mexico
PAMA(1) Price
Arizona $897
167M Texas Montana
120M
Illinois $361
$336
$236
100M
CareFirst
Louisiana $125
80M Arkansas
Michigan
Goal: Targeted Growth with Positive
Medical Policy Decisions
Novitas
2014 2015 2016 2017 2018
2018-2020
§ Cigna added OVA1 to its national preferred coverage list in § OVA1 PAMA price set for 2018 – 2020 = $897
January 2019 § CPT code 81503
§ 51% of the population now under positive coverage
(1) Protecting Access to Medicare Act of 2014 (PAMA).
23Current Financial Priorities
Margin Expansion
24Catalysts Driven Momentum Through 2019
On track to deliver strong results in 2019
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
Validation preferred coverage list Expanded Bio-
§ Q4 2018, presented § 15 M lives added (167M total number covered informatics
CA125 disparity data at lives as of Q1 2019) Platform- Beyond
the Mid-Atlantic Proteins
Gynecologic Oncology Expanding Sales Team
Society § Phase 2 hiring completed in Q1 2019 (11 FTE)
Decentralized 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 (2H 2019)
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)
25Compelling Growth Strategies
Expand
Distribution
Platform
Beyond the U.S. by
launching OVA1 Plus
while building the clinical
Enterprise Value
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
26Investment 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 that is incorporated into clinical treatment
guidelines
Strong commercialization strategy addressing sizable potential markets
Pipeline of compelling diagnostic bioinformatic product candidates
Strong intellectual property protecting methods and use
Broad managed care coverage: 2018 Clinical Laboratory Fee Schedule (“CLFS”)
reimbursement rate of $897
Seasoned management teamAppendix
Trusted Solution: Care Pathway Guidelines
Published Evidence OVAI (MIA) Guidelines / Position Statements(1)
Ueland, et al Obstetrics and Gynecology, 2011
ACOG Practice Bulletin
Number 174, November 2016, page 10
Gynecologic Oncology, 2013 Am J Gynecol,
Bristow, et al.
201
Longoria, et al. Am J Obstet Gynecol, 2013 National Comprehensive Cancer Network
Guidelines, Version 5, 2017
Updated Feb 2, 2018
Goodrich, et al. Am J Obstet Gynecol, 2015
Forde, et al. Curr Med Res Opin, 2015
Society of Gynecologic Oncology Position
Statements Issued 2011 Updated 2013
Coleman, et al. Am J Obstet Gynecol, 2016
Eskander, et al. Am J Obstet Gynecol, 2016
Urban, et al. Int. J Gynecol Cancer, 2017 (1)In 100% of all Key Guidelines
Brodsky, et al. Am Health & Drug Benefits, 2017
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
Cleared (MRI,
§ Vermillion is the first company to Blood 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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