vermillion (vrml) investor presentation 2013-04-10

7/30/2019 Vermillion (VRML) Investor Presentation 2013-04-10

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Corporate PresentationApril 2013

NASDAQ:VRML


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NASDAQ:VRML

The following information contains certain forward-looking statements relating to the companys

business, which can be identified by the use of forward-looking terminology such as estimates,believes, expects, may, are expected to, will, will continue, should, would be, seeks,

pending, anticipates, the negative version of these words and other similar expressions, or by

discussions of strategy, plans or intentions. Such statements include descriptions of the companys

investment and research and development programs and anticipated expenditures in connection

therewith, descriptions of new products expected to be introduced by the company and anticipated

customer demand for such products and products in the companys existing portfolio. Such

statements reflect the current views of the company with respect to future events and are subject tocertain risks, uncertainties and assumptions, including those described in the companys most recent

Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Many factors could cause the

actual results, performance or achievements of the company to be materially different from any

future results, performances or achievements that may be expressed or implied by such forward-

looking statements. Should one or more of these risks or uncertainties materialize, or should

underlying assumptions prove incorrect, actual results may vary materially from those describedherein as anticipated, believed, estimated or expected.

This presentation is copyright 2012-2013 by Vermillion, Inc. All Rights Reserved.

All logos, trademarks and brand names used in this presentation are the property of Vermillion or

belong to their respective owners.

Forward-Looking Statements

1


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NASDAQ:VRML

To become a recognized leader

in the advancement of womens

health by providing innovativemethods that detect, monitor

and manage the treatment of

gynecologic cancers

Corporate Vision

2


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NASDAQ:VRML

We collaborate with prestigious research

institutions to advance our product developmentprograms in gynecologic oncology diagnostics

We work with physician champions to conduct

studies focused on quality of care and health

economics benefits, to enable positive coverage

decisions and inclusion in medical guidelines

We promote utilization of our products by

advancing from CLIA-LDT to FDA clearance,

securing Category I CPT codes and driving

favorable state and national coverage decisions

Leveraging these core competencies, our flagship

product, OVA1, is the firstFDA-cleared,multi-

biomarker blood test for pre-surgical diagnosis of

ovarian cancer. OVA1 represents anew classof

software-based diagnostics

Vermillion is an Industry Leader inMultivariate Diagnostics

3

Collaborators

Strategic Partner

Unique Capabilities Support Opportunities in Gynecologic Oncology


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NASDAQ:VRML

Financial Highlights (12/31/12)

Cash $8.0M

Revenue (ttm) $2.1M

Total Assets (mrq) $8.6M

Total Debt $1.1M

Total Liabilities (mrq) $4.0M

Total Equity (mrq) $4.7M

Stock Key Stats(1)

Stock Price (3/28/2013) $1.20

52 Week Low/High $1.13-$2.79

Avg. Daily Vol. (3 mo.) 64,308

Shares Outstanding 15.2MPublic Float, est. 13.5M

Inst. Holdings, est. (mrq) 15.0%

Insider Holdings, est. 3.9%

Market Cap. $18.4M

Enterprise Value $11.5M

EV/Revenue (TTM) 5.5x

1. Data Source: S&P Capital IQ & Company Management

Note: Institutional holdings includes non-filers and 860,595 shares held by Quest Diagnostics.

Key Stats: VRML (NASDAQ GM)

4


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NASDAQ:VRML

Lifetime risk of developing ovarian cancer: 1 in 71

Ovarian cancer is called the Silent Killer since it oftengoes unnoticed, making early detection key to survival3

More than 1 million adnexal masses (aka tumors or cysts)

detected annually in the U.S.

Estimated 300,000 adnexal surgeries/yr of which about

22,000 result in finding cancer Only 19% are diagnosed as malignant before the cancer

spreads (metastases)

15,000 US deaths annually deadliest gynecologic

cancer and 5th leading cause of cancer death in women

Only 1 in 3 women with ovarian cancer are initiallytreated by a gynecologic oncologist, in part due to

inadequate diagnostic tests and procedures

Overall 5-year survival rates lag far behind other

cancers, despite well-documented survival advantage

for those operated by a gynecologic oncologist

OVA1 Addresses Unmet Clinical Need forBetter Diagnosis of Ovarian Cancer

5

Stage % ofCases

5-year SurvivalRate

I 24% 95%

II 6% 65%

III 55% 15-30%

IV 15% 0-20%Source:AmericanCancerSociet

y

Key to Survival: Early Detection

Adnexal

Mass

3. Surveillance, Epidemiology, and End Results, Stage Distribution and 5-year Relative Survival by Stage at Diagnosis for 2001-2007,


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NASDAQ:VRML

CA125 Blood TestTransvaginal

Ultrasound/Imaging

Limited # of Gynecologic

Oncologists (GOs)

Before OVA1, CA125 was the

only existing blood test for

Ovarian Cancer

Unreliable: 50% false

negatives for early stage

ovarian cancers

Misleading: Elevated levels

can be caused by other

conditions (i.e., benign

ovarian tumors,

endometriosis)

Unreliable: evaluation not

standardized, too subjective

Variable: Results

dependent on the varying

skill & experience of the

Ultrasound operator

Physical exam not

conclusive

Just 1,000 Gynecologic

Oncologists in the U.S.

100,000 FamilyPractitioners in U.S.

50,000 GeneralSurgeons

50,000Internists

35,000OB/GYNS

~1,000GOs

Whats the Problem with theTraditional Approach to Diagnosis?

6


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NASDAQ:VRML

Widespread Flaws Found in Ovarian Cancer Care - NY

Times front page, Mar. 11, 2013 Inadequate Treatment of Ovarian Cancer - NY Times

editorial, Mar. 13, 2013

Also reported by NBC Nightly News with Brian Williams(Mar. 13, 2013)

This news coverage focused on a clinical study ofpatientaccess to optimal carein ovarian cancer by Dr. Robert

Bristow, who also led our OVA500 pivotal study (sl. 18, 19)

Key findings:

Of 13,000 ovarian cancer patients treated between 1999 - 2006, only

37% received the care recommended by NCCN, an alliance of 21major cancer centers across the USA

Women who received the recommended NCCN standard of care were

30% less likely to die

Even with advanced cancer, recommended treatment allowed 35% of

patients to survive at least 5 years, compared with 25% when the

standard was not followed

The Problem?Patient Access to Optimal Care

7

If we could just make

sure that women get to

the people who are

trained to take care of

them, the impact

would be much greater

than that of any new

chemotherapeutic

drug.- Dr. Robert

Bristow


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NASDAQ:VRML

OVA1 is an FDA-cleared blood test to help

physicians assess the probability that ovarian

masses are malignant or benign prior to surgery

With 96% sensitivity, OVA1 may help refer cancers

to oncology specialists, while 95% negative

predictive value (NPV) helps ensure benign cases

are treated in a local setting.4

OVA1 is the first FDA-cleared, protein-based, In

Vitro Diagnostic Multi-Variate Index Assay (aka

multi-biomarker test) and represents a new

class of software-based diagnostics

AMA assigned a unique Category 1 CPT Code to

OVA1 effective January 1, 2013

The Solution: OVA1

8

As physicians who are

expert in the care of womenwith gynecologic cancers,

members of the SGO are

supportive of scientific

advances such as OVA1 that

may help healthcare

providers better detectwhen referral to a

gynecologic oncologist is

indicated.

Society of Gynecologic

Oncology, Sept 2009 5

4. Ueland FR, DeSimone CP, Seamon LG, et al. Obstet Gynecol. 2011;117(6):1289-1297.

5. http://www.sgo.org/newsroom/position-statements-2/ova1/


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NASDAQ:VRMLHow OVA1 Works

9

Using OvaCalc, Vermillion's FDA-cleared

software device, OVA1 evaluates 5 proteins

found in the blood which increase or

decrease if you have ovarian cancer

The OvaCalc algorithm

combines the 5 results into a

single numerical test value

that expresses the probability

of malignancy


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NASDAQ:VRMLOVA1 Diagnostic Pathway

10

Before a generalist removes an ovarian mass,

OVA1 can help identify patients at higher risk of malignancy,for whom specialist involvement is appropriate

Ovarian

MassClinical

Impression

Surgery

Planned

Lower

Probability of

Cancer

Ob/Gyn

Higher

Probability ofCancer

Specialist

Involved


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NASDAQ:VRML

Subjects OVA1 CA125-II

All cancer (n=161) 96% 69%

All epithelial ovarian cancer(EOC; n=94)

99% 83%

Early stage EOC (n=40) 98% 68%

Premenopausal women with

early stage EOC (n=14)93% 36%

Sensitivity NPV

Clinical Impression (CI) 75% 88%

OVA1 + CI 96% 95%

OVA1 Improves Upon Clinical Impression Performance by Cancer Stage

OVA1 is Superior to CA125-II

The combination of OVA1 and physician's pre-

surgical assessment identified primary ovarian

malignancies in 90% of Stage I cancers and 100% in

Stage II and Stage III patients

OVA1 identified 99% of all EOC &98% of all early stage EOCs

OVA1 had 93% sensitivity for

premenopausal early stage EOC vs.

36% for CA125-II

OVA1 FDA Clearance Data4



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OVA500 KEY TAKEAWAYS

Outstanding performance reported in early-

stage ovarian cancer and across a broad

range of malignancy subtypes

>1,000 patients in combined OVA1 clinical

studies with a total of 259 malignancies

Overall both studies identified 93% (78/84)

early-stage ovarian malignancies

Confirms the unrivaled sensitivity of OVA1

for early-stage adnexal malignancies in the

critical population of premenopausal

women

Gynecologic Oncologypublished OVA500

clinical study in February 2013

OVA1: OVA500 Multi-Center Study7

Principal Investigator for

the second OVA1 study,

Dr. Bristow has authored

four books and published

numerous research

articles on ovarian cancer

Thanks to diagnostic advances like OVA1,

there is real hope that the majority of

women with ovarian cancer will undergo

surgery by a qualified gynecologiconcologist, which is one of the most

powerful determinants of survival.

Dr. Robert E. Bristow

Director of Gynecologic Oncology Services

UC Irvine Healthcare

7. R.E. Bristow et al. / Gynecologic Oncology 128 (2013) 25225912


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Risk StratificationPerformance

OVA1Sensitivity

Overall 92%

Early Stage Disease 91%

Premenopausal Patients 94%Premenopausal in early

stage w/ specificity of 61%91%

Combined w/Physician Assessment

Sensitivity NPV

Overall 96% 98%

Premenopausal

Population94%

Early Stage Ovarian

Cancer (Stage I & II)91%

New OVA500 multi-site study confirmed &extended the original pivotal study results:

13

OVA500 Multi-Center Study Results

OVA1: OVA500 Multi-Center Study7

7. R.E. Bristow et al. / Gynecologic Oncology 128 (2013) 252259


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14

How Might OVA1 Impact Generalists?

Predicted OVA1 Impact on Percent of Cancers Missed

Predicted OVA1 Impact on Gyn-Onc Referral of Benign Patients

Study Results of % of Cancers Missed

Evaluation Method Ueland Bristow Combined

Clinical Assessment Alone26.1%(N=516)

24.8%(N=494)

25.3%(N=1,100)

Clinical Assessment + OVA1

4.3%

(N=516)

4.3%

(N=494)

4.3%

(N=1,100)

Ueland Bristow Combined

Total number of benign surgeries 363 402 765

Benign patients referred to Gyn-Onc for surgery 71.9%(261/363)

50.0%(201/402)

60.4%(462/765)

Incorrect risk stratification of benign patients by

OVA1 potentially leading to referral (False

Positive Rate)

57.2%(203/355)

46.5%(187/402)

51.5%(390/757)

Predicted misclassification of benign patients by

Clinical Assessment+OVA1 (logical OR function) 65.4%(232/355) 49.3%(198/402) 56.8%(430/757)

OVA1 detected

53 of 64 cancers

(83%) missed

by Clinical

Assessment

Referral of

benign patients

predicted to be

no higher than

currently found


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NASDAQ:VRML

21M

36M

47M

2010 2011 2012

Total Lives Currently Covered with OVA1

27 Blue Cross Blue Shield

(BCBS)47 million

Medicare / Medicare

Advantage45 million

Department of Defense 1.4 millionOther payors contracted

with Quest Diagnostics1.5 million

Total 94.9 million

BCBS Coverage Expanding

Highmark of Medicare coverageestablished in March 2010: $516.25 per

test

Department of Defense coverage initiated

Q1 2012 at list price: $650 per test

OVA1 Expanding Coverage &Favorable Pricing

15

(Millions of Lives)


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NASDAQ:VRML

OVA1 partnership economics: Quest

Diagnostics pays Vermillion $50 per test plus

33% of Quest Diagnostics gross profit per test

Exclusive rights through 2014 with option for2015

Development phase of alliance being closed out

Paid back development loan in 2011

In negotiations to close out development phase

and define future relationship

Regular steering committee meetings to

enhance business relationship

Quest Diagnostics Alliance

16

Potential OVA1 Testing

Locations

Physician

Offices 10-

20%

Ref Labs,

e.g.

Quest,

LabCorp

~30%

Hospital

Labs 50-

55%


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NASDAQ:VRML

Growth in OVA1 Tests

Performed Since FDA Clearance

6,192

15,227

16,460

2010 2011 2012

Nearly 40K tests ordered since 2010 launch

>5,500 ordering physicians to date

More than 30 Key Opinion Leaders in the

speaker bureau

Two peer review publications in June 2011

Increasingly supported by positive coveragedecisions, i.e., Medicare and Blue Cross Blue

Shield

Positive statements by ACOG & SGO

OVA500 study published by Gynecologic

Oncology in February 2013

Granted unique CPT code, effective Jan. 2013

OVA1 Clinical & Commercial SuccessDemonstrates Strong Growth Opportunity

17

Q1 2013: Expecting 4,250 to

4,550 tests to be performed99. Guidance issued on February 20, 2013


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NASDAQ:VRMLOvarian Cancer Roadmap

Product Purpose or Upgrade

Doctor Type

ProductEstimated

Launch

Gyn-

Onc OB/GYN

Current OVA1: patient triage/referral to Gyn-Onc X OVA1 Launched

Provide CA125 result for cancer recurrence

baselineX OVA1 2013

Re-launch OVA1 on a single, top-4 IVD platform X OVA1+ 2014

Aid in diagnosis for patients referred to Gyn-Onc X OVA1+ 2015

Next-gen OVA1 with reduced FPR, increased PPV X X OVA2 2015*

*Assumes fast-track option with licensing is successful

Strategic imperative: give the Gyn-Onc a reason to require OVA1 in patient workup

#1 Gyn-Onc request is release of CA125 result as baseline for post-operative

monitoring for recurrence of a malignancy

Importance of re-launch on a top-4 platform discussed in a later slide

Aid in diagnosis claim enables Gyn-Onc to use OVA1 score to estimate likelihood of

cancer, in conjunction with imaging or other factors

OVA2: Platform for entry into high-risk monitoring, prognosis and other indications

18


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Instruments common to most US Clin Chem

reference labs and hospitals

Adds OVA1 to their oncology/repro menu

Automate & simplify OVA1 test ordering,

execution, QC & results reporting

Strong presence in markets outside USA

WW Regulatory and commercial capabilities

Strategic development/commercialization

partner for future multi-marker tests

Re-Launch OVA1 on a MajorAutomated IVD Platform

19(1) Estimated milestone dates. Objectives are not placed in any specific order.

Top 4: Siemens, Roche, Abbott and Beckman Coulter (Danaher)

Strategic Goal: Dramatically expand OVA1 commercial reach

with a top-tier IVD laboratory systems partner, leveraging theirworldwide installed base of instruments and customers.

Key Objectives:1 Why Partner?

Phase 1

Prioritize based on market share/OVA1 menu

Initiate Bus Devt discussions

Platform migration algorithm optimization

Validation with Ueland/Bristow study samples 510(k) showing substantial equivalence

Phase 2

OVA1 ordered directly from LIS, reported to LIS

5-component tests automatically generated

On-board, automated OVA1 calculation


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NASDAQ:VRML

No loss of current OVA1 advantages

Sensitivity, NPV, detection of early stage

cancer and broad range of tumor subtypes

Improve specificity to 75% at same time

PPV around 50% or higher

Five or fewer biomarkers

Use IVD-cleared component kits if possible

Validate using existing patient serum

samples if possible

OVA2: Technology Foundationfor Next-Generation Products

20

Strategic Goal:Improve specificity and PPV without sacrificing current

OVA1 strengths, as a technology foundation supporting OVA1 adoption asa standard of care. Will also support expanded claims and new line

extensions as an aid in ovarian cancer diagnosis and patient management.

Key Objectives1:

OVA2 Technology Design Goals Protect IP and publish results ofBiomarker Bakeoff completed in 2012

Complete Freedom to Operate diligence

and engage licensing partners as needed

Fast-Track Option (goal: EOY 2014-2015)

License only IVD-cleared components

Lower Devt cost & risk; far less Devt work

Backup Option (likely 2016 or later)

Two research-grade IAs required

Conversion to IVD-grade costly, expensive(1) Estimated milestone dates. Objectives are not placed in any specific order.


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NASDAQ:VRML

Maximize the Current OVA1 Opportunity

Vermillion performs as primary commercialization driver Growth could be further accelerated by non-exclusive relationship with Quest

Dedicated Technical Support for Patients and Providers

Guidelines Driven by New Clinical and Economic Data, Conferences and Publications

Coverage from National Plans and Improved Payment Experience

Expand the OVA1 Customer Base

Re-Launch OVA1 on Major Automated Platform with Strategic Partner

Expand the addressable market into hospital based testing

Increased lab placements

Non-US licensing and collaborations

Expand the Patient Base with Next Generation Performance Levels

Improve specificity and PPV drive market penetration & expanded claims

With KOL support, pursue Gyn-Onc use as aid in diagnosis & surgical planning

CLIA-LDT followed by new FDA submission for high risk patient monitoring

2013-2015 Focus on Expanding theCommercial Franchise

21


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NASDAQ:VRML

BUSINESS PLAN OVERVIEW &COMPANY INFORMATION


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NASDAQ:VRMLManagement Team

23

Proven success in delivering value for investors through expertise in diagnostic test

development and commercialization

Title Experience

Thomas McLain President and CEOClaro Scientific, Nabi Biopharmaceuticals,

Bausch & Lomb, Ernst & Young

DonaldMunroe, Ph.D.

SVP Business

Development and

Chief Scientific

Officer

Beckman Coulter, Invitrogen Corporation,

Corning (Microarray Technologies), R.W.

Johnson Pharmaceutical Research Institute,

Allelix Biopharmaceuticals

William CreechVP, Sales &

Marketing

Capitol Vial, Apogent Technologies, Chiron

Diagnostics, Abbott Diagnostics

Eric SchoenChief Accounting

Officer

Borland Software, Trilogy Enterprises,Momentum SI, Alticast,

PricewaterhouseCoopers


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NASDAQ:VRMLBoard of Directors

24

Established Board of Directors with proven expertise in diagnostic test

development and commercialization

Title Experience

Bruce HuebnerChairman of the

Board

Hybritech, Gen-Probe, Nanogen, Osmetech

Molecular Diagnostics

James Burns Director

AssureRX, Entremed, MedPointe, Osiris

Therapeutics

Robert Goggin Director Keller & Goggin, P.C.

Peter Roddy Director

Pain Therapeutics, COR Therapeutics, MCM

Laboratories, Hewlett-Packard, Price

Waterhouse

Carl

SeveringhausDirector Tecan Americas, American Monitor Corporation

William

Wallen, Ph.D.Director

IDEXX Laboratories, Bayer Healthcare, Becton

Dickenson, Wampole Laboratories


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September OVA1 cleared by FDA

March OVA1 launched and Medicare issued coverage

September CE Mark for OVA1 October OVA1 high sensitivity data presented at IGCS

January PAD biomarker patent granted

March OVA1 high sensitivity data & OVA2 biomarker data presented at SGO

OVA1 referenced in updated ACOG/SGO committee opinion

May Notice of allowance for PAD biomarker panel patent and Alzheimer patent

June Two OVA1 peer reviewed articles published in Obstetrics & Gynecology

September Data highlighting improved sensitivity when imaging is combined with OVA1

November Notice of allowance for 5th PAD biomarker patent

December Acquired assets of Correlogic

March DOD contract

Received Category 1 CPT code for OVA1

May Expanded coverage to 93M lives

October Published PAD study in online peer-reviewed journal, Vascular Medicine

November OVA500 clinical study published in Gynecologic Oncology

January Launch new CPT Code

March OVA500 clinical study data presented at SGO by Dr. Bristow

Vermillion announces seeking partner for PAD program

25

2012

2011

2010

2009

2013

Company Accomplishments

Future Investment will Expand the


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NASDAQ:VRML

Complementary Diagnostics

Maintain Gynecologist/Gynecologic Oncologist focus

Ovarian, cervical, endometrial and uterine cancers

Drug selection/companion diagnostics

CLIA/CAP Accredited Laboratory

Portfolio of CLIA-LDTs and FDA Approved Tests

Focus on delivering combination of improved quality, cost saving

and differentiation to healthcare providers

Expand Commercial Platform to Include Molecular and

Metabolic Testing

Future Investment will Expand theProduct Portfolio

26


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NASDAQ:VRML

Vermillion is an industry leader in Multi Marker

IVD and Gynecologic Cancer Demonstrated success with first commercial

product:

Nearly 40k tests ordered through 2012

5,500 ordering physicians to date

Strengthening trends in OVA1 payer coverage and

adoption

New CPT code, effective January 1, 2013

New OVA500 study confirms the original pivotal

study, supporting guidelines for OVA1 as a new

standard of care for Ovarian Tumor risk assessment

Unique strengths and firsts equip Vermillion

with a re-usable biomarker translation playbook

Broad patent portfolio supports corporate

strategy

Key Takeaways

27


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NASDAQ:VRML

Corporate Headquarters

Vermillion, Inc.

12117 Bee Caves Rd.Austin, TX 78738

Tel: (512) 519.0400

Fax: (512) 439.6980

www.vermillion.com

Investor Relations

Ron Both

Liolios Group, Inc.(949) 574.3860

[email protected]

28

Contact Information


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NASDAQ:VRML

APPENDIX

29

Hi i l Fi i l I f i


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NASDAQ:VRMLHistorical Financial Information(Amounts in Thousands, Except Share and Par Value Amounts; Unaudited)

2012 2011

Assets

Current assets:

Cash and cash equivalents $ 8,007 $ 22,477

Accounts receivable 137 99

Prepaid expenses and other current assets 348 317

Total current assets 8,492 22,893

Property and equipment, net 142 216

Other ass ets - 2

Total assets $ 8,634 $ 23,111

Liabilities and Stockholders Equity

Current liabilities :

Accounts payable $ 525 $ 1,331

Accrued liabilities 1,074 2,592

Short-term debt 1,106 7,000

Deferred revenue 492 553

Total current liabilities 3,197 11,476

Non-current liabilities:

Long-term deferred revenue 770 1,224

Other liabilities - 52

Total liabilities 3,967 12,752

Commitments and contingenciesStockholders equity:

Preferred stock, $0.001 par value, 5,000,000 shares authorized, none

issued and outstanding at December31, 2012 and 2011 - -

Common stock, $0.001 par value, 150,000,000 shares authorized;

15,200,079 and 14,900,831 shares issued and outstanding at

December31, 2012 and 2011, respectively 15 15

Additional paid-in capital 328,097 326,796

Accumulated deficit (323,445) (316,299)

Accumulated other comprehensive loss - (153)

Total stockholders equity 4,667 10,359Total liabilities and stockholders equity $ 8,634 $ 23,111

December 31,

30

Hi t i l Fi i l I f ti


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NASDAQ:VRMLHistorical Financial Information(Amounts in Thousands, Except Share and Per Share Amounts; Unaudited)

31

2012 2011 2012 2011

Revenue:

Product $ 1,029 $ 755 $ 1,640 $ 1,469

License 113 113 454 454

Total revenue 1,142 868 2,094 1,923

Cost of revenue:

Product 32 24 131 129

Total cost of revenue 32 24 131 129

Gross profit 1,110 844 1,963 1,794

Operating expenses:

Research and development(1) 333 1,168 2,216 5,387

Sales and marketing(2) 931 1,219 4,653 5,539

General and administrative(3) 1,127 1,527 4,508 8,509Total operating expenses 2,391 3,914 11,377 19,435

Loss from Operations (1,281) (3,070) (9,414) (17,641)

Interest inc ome 5 9 28 64

Interest expense (9) (66) (206) (396)

Gain on sale of instrument business - - 1,830 -

Gain on litigation settlement, net - - 710 -

Change in fair value of warrants - 4 - 378

Reorganization items - (22) 88 (96)

Other expense, net (90) 10 (182) (99)

Loss before i ncome taxes (1,375) (3,135) (7,146) (17,790)

Income tax benefit (expense) - - - -

Net loss $ (1,375) $ (3,135) $ (7,146) $ (17,790)

Loss per share - basic and diluted $ (0.09) $ (0.21) $ (0.48) $ (1.25)

Weighted average common shares us ed to compute basi c a nd dil uted net

loss per common share 15,124,012 14,866,848 15,010,868 14,249,570

Non-cash stock-based compensation expense included in operating expenses:

(1) Research and development 28$ 96$ 127$ 686$

(2) Sales and marketing 55 36 203 158

(3) General and administrative 413 182 965 2,446

Three months ended December 31, Year Ended December 31,

Renowned Clinical Partnerships


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NASDAQ:VRML

Fred Ueland (U Kentucky) OVA1 validation & launch

Dr. J. Cooke (Stanford) & Dr. W. Hiatt (U. Colorado) PAD studies

Robert Bristow (UC Irvine) OVA500 and follow-on publications

Further collaborations expected to be announced in 2013

Independent Clinical Studies Program

Low-cost clinical research collaborations on 2nd-tier priorities

VRML offers FOC testing and biomarker/algorithm support in return for 1st

right of refusal on IP licensing and product opportunities

PRs & publications further drive Vermillion brand recognition & credibility

Current or proposed collaborations on expanded claims, novel patient

management protocols, BRCA patient monitoring, prognosis & recurrence

Renowned Clinical PartnershipsSet the Stage for Success(1)

32(1) Estimated. Expected milestones are not placed in any specific order within years.


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SUPPLEMENTAL OVA1 SLIDES

Why it works: OVA1 Score Correlates


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NASDAQ:VRML

Why it works: OVA1 Score Correlateswith Probability of Malignancy4

Research has shown that

as the OVA1 score

increases, there is an

increasing probability ofovarian malignancy

Percent of Elevated OVA1 Score Having Malignancy



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NASDAQ:VRMLValidated Through 44 Clinical Sites4,6,7

Study 1 sites: 17

Study 2 sites : 17

Study 1 & 2 sites: 10

Total: 44

Two prospective clinical trials

>1,000 adnexal surgeries >250 various malignancies

3 separate publications


6. Miller R, Smith A, DeSimone C, et al. Obstet Gynecol. 2011;117(6):1298-1306.

7. R.E. Bristow et al. / Gynecologic Oncology 128 (2013) 252259 35


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NASDAQ:VRML

OVA1 (n=) 39/40 52/52 57/68 149/161

ROMA(n=) 9/12 36/36 27/41 72/89

4. Ueland FR, DeSimone CP, Seamon LG, et al. Obstet Gynecol. 2011;117(6):1289-12978. ROMA (HE4 EIA + Architect CA125 II) Instructions For Use, 2011-09, Fujirebio Diagnostics, Inc.

Comparison with ROMA Algorithm

36

Risk Stratification Sensitivity of OVA14

& ROMA8

98% 100%

84%93%

75%

100%

66%

81%

Early Stage Late Stage Non EOC All Cancers Studied

OVA1 maintains a high level of sensitivity across a broad range of malignancy subtypes

OVA1 provides a minimal rate of cancers missed of 7% compared to 17%

New AMA CPT Code a Watershed


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NASDAQ:VRML

AMA assigned a unique Category 1 CPT

Code to OVA1 effective January 1, 2013

Replaces physicians use of problematic

generic code when billing insurance

companies

Code streamlines claim processing

Approval supported by several peer-

reviewed publications and positive

insurance coverage decisions, including

Medicare

CMS (Centers for Medicare & Medicaid

Services) will use gap-fill process to

determine CPT code Medicare pricing using

1st year data

New AMA CPT Code a WatershedIndustry Milestone

37

CPT (Current Procedural

Terminology) codes are published

by the American Medical

Association (AMA)

They provides uniform language

that accurately describes medical,

surgical, and diagnostic services.

Q Di i Alli


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NASDAQ:VRMLQuest Diagnostics Alliance

Est. Market,Annual TestsCurrent OVA1Sales

ReferenceLabs 90,000 18%

PhysicianOffices 60,000 0%

Untappedmarket

HospitalLabs 150,000 0%

Quest providing logistic, billing, and collection support

Vermillions 9 sales reps primary drivers of sales

Company planning on increasing sales reps in select territories with

insurance coverage to ramp sales growth

Over 5,500 physicians have ordered OVA1

Along with de-novo growth, objectives will be to increase organic growth

with key initiative to drive reorder rates

38

Summary of Vermillion's Diagnostic


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NASDAQ:VRML

28 new patents (WW) granted or allowed since January 2011

4 new ovarian biomarker patent families acquired from Correlogic

>65 patents pending across disease areas in U.S. and abroad

39

Disease Area

Patents Granted

FamiliesU.S. Non-U.S. Total

Ovarian cancer 5 27 32 14

Breast cancer 1 1 2 3

Alzheimer's disease 3 6 9 3

PAD 6 2 8 4

Other 11 10 21 8

TOTAL 26 46 72 32

Summary of Vermillion s DiagnosticPatent Portfolio


41/43

NASDAQ:VRML

Vascular Medicine ProgramRisk Assessment for PeripheralArtery Disease (PAD)

PAD Unmet Need & Market


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NASDAQ:VRML

What is Peripheral Artery Disease? 10 million people with PAD in the U.S. many

undiagnosed

11

Prevalence high in diabetic and elderly

populations, both to grow in coming years

Total at-risk population totals 59+ million

Early diagnosis and treatment of PAD could

prevent disability and save lives12

Currently no blood test for PAD and no reliable

or practical diagnostic alternatives

PAD Unmet Need & MarketOpportunity

41

In the next five years, 1 in 4 patients

with PAD will suffer a heart attack,

stroke, amputation or death.13

11. Society for Vascular Medicine, June 2012

12. PAD Coalition 1Q 2008

13. PARTNERS study (Hirsch et at, JAMA 2001)14. American Heart Association Recommended Testing

At Risk Group14 U.S. Population(Millions)

Diabetics aged 50+ 13

Smokers aged 50+ 20

Elderly aged 65+ 38

Group Overlap (12)

Total At-Risk Population 59 Million

Normal ArteryPAD-Inflicted Artery

(atherosclerotic)

Positive Results from PAD Intended


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NASDAQ:VRML

1,025 subjects were studied by researchers at

Stanford Univ. School of Medicine and Univ. of

Colorado

Vermillion's biomarker test identified PAD in 17 of

20 (85%) of patients missed by using conventionalclinical assessment alone

Results were published in the prestigious peer-

reviewed journal, Vascular Medicine15

Currently seeking strategic partner(s) to further

PAD development & commercialization

Positive Results from PAD IntendedUse Study

PAD study results published in

Vascular Medicine, Oct. 2012

Results indicate this biomarker

model is a useful adjunctive tool

thatadds independent value to a

clinical risk score in the target

population of low to moderate

Framingham risk.

vermillion (vrml) investor presentation 2013-04-10

Documents