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Corporate Presentation

April 2013

Forward-Looking Statements


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 to certain 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 forwardlooking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein 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.

Corporate Vision


To become a recognized leader in the advancement of womens health by providing innovative methods that detect, monitor and manage the treatment of gynecologic cancers

Vermillion is an Industry Leader in Multivariate Diagnostics


We collaborate with prestigious research institutions to advance our product development programs 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 first FDA-cleared, multibiomarker blood test for pre-surgical diagnosis of ovarian cancer. OVA1 represents a new class of software-based diagnostics


Strategic Partner

Unique Capabilities Support Opportunities in Gynecologic Oncology



Stock Key Stats(1)
Stock Price (3/28/2013) $1.20


Financial Highlights (12/31/12)

Cash Revenue (ttm) Total Assets (mrq) Total Debt Total Liabilities (mrq) Total Equity (mrq) $8.0M $2.1M $8.6M $1.1M $4.0M $4.7M

52 Week Low/High
Avg. Daily Vol. (3 mo.) Shares Outstanding Public Float, est. Inst. Holdings, est. (mrq) Insider Holdings, est. Market Cap.

64,308 15.2M 13.5M 15.0% 3.9% $18.4M

Enterprise Value
EV/Revenue (TTM)


1. Data Source: S&P Capital IQ & Company Management Note: Institutional holdings includes non-filers and 860,595 shares held by Quest Diagnostics.

OVA1 Addresses Unmet Clinical Need for Better Diagnosis of Ovarian Cancer


Lifetime risk of developing ovarian cancer: 1 in 71 Ovarian cancer is called the Silent Killer since it often goes 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
Adnexal Mass
Key to Survival: Early Detection
Source: American Cancer Society

% of Cases 24% 6% 55% 15%

5-year Survival Rate 95% 65% 15-30% 0-20%

Only 1 in 3 women with ovarian cancer are initially treated 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

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

Whats the Problem with the Traditional Approach to Diagnosis?


CA125 Blood Test

Before OVA1, CA125 was the only existing blood test for Ovarian Cancer Unreliable: 50% false negatives for early stage ovarian cancers

Transvaginal Ultrasound/Imaging
Unreliable: evaluation not standardized, too subjective Variable: Results dependent on the varying skill & experience of the Ultrasound operator

Limited # of Gynecologic Oncologists (GOs)

100,000 Family Practitioners in U.S. 50,000 General Surgeons 50,000 Internists
35,000 OB/GYNS ~1,000 GOs

Misleading: Elevated levels can be caused by other conditions (i.e., benign ovarian tumors, endometriosis)

Physical exam not conclusive

Just 1,000 Gynecologic Oncologists in the U.S.


The Problem? Patient Access to Optimal Care


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 of patient access to optimal care in ovarian cancer by Dr. Robert Bristow, who also led our OVA500 pivotal study (sl. 18, 19) Key findings:

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

Of 13,000 ovarian cancer patients treated between 1999 - 2006, only 37% received the care recommended by NCCN, an alliance of 21 major cancer centers across the USA Women who received the recommended NCCN standard of care were 30% less likely to die

drug.- Dr. Robert


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 Solution: OVA1


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

As physicians who are expert in the care of women with gynecologic cancers, members of the SGO are supportive of scientific advances such as OVA1 that may help healthcare providers better detect when 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/

How OVA1 Works

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

OVA1 Diagnostic Pathway

Before a generalist removes an ovarian mass, OVA1 can help identify patients at higher risk of malignancy, for whom specialist involvement is appropriate
Lower Probability of Cancer



Ovarian Mass

Clinical Impression

Surgery Planned
Higher Probability of Cancer

Specialist Involved


OVA1 FDA Clearance Data4

OVA1 Improves Upon Clinical Impression
Sensitivity NPV


Performance by Cancer Stage

Clinical Impression (CI) OVA1 + CI

75% 96%

88% 95%

OVA1 is Superior to CA125-II

Subjects OVA1 CA125-II

The combination of OVA1 and physician's presurgical assessment identified primary ovarian malignancies in 90% of Stage I cancers and 100% in Stage II and Stage III patients

All cancer (n=161) All epithelial ovarian cancer (EOC; n=94) Early stage EOC (n=40)

96% 99% 98% 93%

69% 83% 68% 36%

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

Premenopausal women with early stage EOC (n=14)

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


OVA1: OVA500 Multi-Center Study7



Outstanding performance reported in earlystage 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 Oncology published OVA500 clinical study in February 2013

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 gynecologic oncologist, 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) 252259

OVA1: OVA500 Multi-Center Study7

New OVA500 multi-site study confirmed & extended the original pivotal study results:
OVA500 Multi-Center Study Results
Combined w/ Physician Assessment Sensitivity NPV Risk Stratification Performance Overall Early Stage Disease Premenopausal Patients 91%


OVA1 Sensitivity 92% 91% 94% 91%

Premenopausal Population Early Stage Ovarian Cancer (Stage I & II)



Premenopausal in early stage w/ specificity of 61%

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


How Might OVA1 Impact Generalists?

Predicted OVA1 Impact on Percent of Cancers Missed
Study Results of % of Cancers Missed Evaluation Method Clinical Assessment Alone Clinical Assessment + OVA1 Ueland 26.1%


Bristow 24.8%

Combined 25.3%




OVA1 detected 53 of 64 cancers (83%) missed by Clinical Assessment

Predicted OVA1 Impact on Gyn-Onc Referral of Benign Patients

Total number of benign surgeries Benign patients referred to Gyn-Onc for surgery Incorrect risk stratification of benign patients by OVA1 potentially leading to referral (False Positive Rate) Predicted misclassification of benign patients by Clinical Assessment+OVA1 (logical OR function)

Bristow 402 50.0%


Combined 765 60.4%


363 71.9%







Referral of benign patients predicted to be no higher than currently found


OVA1 Expanding Coverage & Favorable Pricing

Total Lives Currently Covered with OVA1


BCBS Coverage Expanding

27 Blue Cross Blue Shield (BCBS)

Medicare / Medicare Advantage Department of Defense Other payors contracted with Quest Diagnostics Total

47 million 45 million 1.4 million 1.5 million 94.9 million

(Millions of Lives)


Highmark of Medicare coverage established in March 2010: $516.25 per test

Department of Defense coverage initiated Q1 2012 at list price: $650 per test





Quest Diagnostics Alliance


Potential OVA1 Testing Locations

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 for 2015 Development phase of alliance being closed out
Paid back development loan in 2011 In negotiations to close out development phase and define future relationship
Hospital Labs 5055%

Physician Offices 1020%

Ref Labs, e.g. Quest, LabCorp ~30%

Regular steering committee meetings to enhance business relationship


OVA1 Clinical & Commercial Success Demonstrates Strong Growth Opportunity

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


Growth in OVA1 Tests Performed Since FDA Clearance

16,460 15,227

Increasingly supported by positive coverage decisions, 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
2010 2011 2012


9. Guidance issued on February 20, 2013

Q1 2013: Expecting 4,250 to 4,550 tests to be performed 9


Ovarian Cancer Roadmap

Doctor Type Product Purpose or Upgrade Current OVA1: patient triage/referral to Gyn-Onc



Estimated Launch
Launched 2013 2014 2015 2015*



Provide CA125 result for cancer recurrence baseline

Re-launch OVA1 on a single, top-4 IVD platform Aid in diagnosis for patients referred to Gyn-Onc Next-gen OVA1 with reduced FPR, increased PPV

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
*Assumes fast-track option with licensing is successful

Re-Launch OVA1 on a Major Automated IVD Platform


Strategic Goal: Dramatically expand OVA1 commercial reach with a top-tier IVD laboratory systems partner, leveraging their worldwide installed base of instruments and customers.
Top 4: Siemens, Roche, Abbott and Beckman Coulter (Danaher)

Key Objectives:1

Why Partner?
Instruments Adds

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

common to most US Clin Chem reference labs and hospitals OVA1 to their oncology/repro menu & simplify OVA1 test ordering, execution, QC & results reporting



presence in markets outside USA

Phase 2
OVA1 ordered directly from LIS, reported to LIS 5-component tests automatically generated

Regulatory and commercial capabilities


development/commercialization partner for future multi-marker tests

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

On-board, automated OVA1 calculation


OVA2: Technology Foundation for Next-Generation Products


Strategic Goal: Improve specificity and PPV without sacrificing current OVA1 strengths, as a technology foundation supporting OVA1 adoption as a standard of care. Will also support expanded claims and new line extensions as an aid in ovarian cancer diagnosis and patient management.

Key Objectives1:

Protect IP and publish results of Biomarker 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

OVA2 Technology Design Goals


loss of current OVA1 advantages

Sensitivity, NPV, detection of early stage cancer and broad range of tumor subtypes

Improve PPV Five Use

specificity to 75% at same time

around 50% or higher or fewer biomarkers IVD-cleared component kits if possible

Backup Option (likely 2016 or later)

Two research-grade IAs required
Conversion to IVD-grade costly, expensive


using existing patient serum samples if possible

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


2013-2015 Focus on Expanding the Commercial Franchise


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 Re-Launch OVA1 on Major Automated Platform with Strategic Partner

Expand the OVA1 Customer Base

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



Management Team


Proven success in delivering value for investors through expertise in diagnostic test development and commercialization Title Thomas McLain President and CEO Donald Munroe, Ph.D. William Creech Eric Schoen SVP Business Development and Chief Scientific Officer VP, Sales & Marketing Chief Accounting Officer Experience Claro Scientific, Nabi Biopharmaceuticals, Bausch & Lomb, Ernst & Young Beckman Coulter, Invitrogen Corporation, Corning (Microarray Technologies), R.W. Johnson Pharmaceutical Research Institute, Allelix Biopharmaceuticals Capitol Vial, Apogent Technologies, Chiron Diagnostics, Abbott Diagnostics Borland Software, Trilogy Enterprises, Momentum SI, Alticast, PricewaterhouseCoopers


Board of Directors
Established Board of Directors with proven expertise in diagnostic test development and commercialization Title Bruce Huebner James Burns Robert Goggin Chairman of the Board Director Director Experience


Hybritech, Gen-Probe, Nanogen, Osmetech Molecular Diagnostics AssureRX, Entremed, MedPointe, Osiris Therapeutics Keller & Goggin, P.C. Pain Therapeutics, COR Therapeutics, MCM Laboratories, Hewlett-Packard, Price Waterhouse Tecan Americas, American Monitor Corporation

Peter Roddy
Carl Severinghaus

Director Director

William Wallen, Ph.D.

IDEXX Laboratories, Bayer Healthcare, Becton Dickenson, Wampole Laboratories


Company Accomplishments
2009 2010

September March September October January March May June

OVA1 cleared by FDA OVA1 launched and Medicare issued coverage CE Mark for OVA1 OVA1 high sensitivity data presented at IGCS PAD biomarker patent granted OVA1 high sensitivity data & OVA2 biomarker data presented at SGO OVA1 referenced in updated ACOG/SGO committee opinion Notice of allowance for PAD biomarker panel patent and Alzheimer patent Two OVA1 peer reviewed articles published in Obstetrics & Gynecology


November December March May October November January March

Data highlighting improved sensitivity when imaging is combined with OVA1

Notice of allowance for 5th PAD biomarker patent Acquired assets of Correlogic DOD contract Received Category 1 CPT code for OVA1 Expanded coverage to 93M lives Published PAD study in online peer-reviewed journal, Vascular Medicine OVA500 clinical study published in Gynecologic Oncology Launch new CPT Code OVA500 clinical study data presented at SGO by Dr. Bristow Vermillion announces seeking partner for PAD program



Future Investment will Expand the Product Portfolio


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


Key Takeaways


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

Contact Information


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 vrml@liolios.com





Historical Financial Information

Assets Current assets: Cash and cash equivalents Accounts receivable Prepaid expenses and other current assets Total current assets Property and equipment, net Other assets Total assets Liabilities and Stockholders Equity Current liabilities: Accounts payable Accrued liabilities Short-term debt Deferred revenue Total current liabilities Non-current liabilities: Long-term deferred revenue Other liabilities Total liabilities Commitments and contingencies Stockholders equity: Preferred stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding at December 31, 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 December 31, 2012 and 2011, respectively Additional paid-in capital Accumulated deficit Accumulated other comprehensive loss Total stockholders equity Total liabilities and stockholders equity

(Amounts in Thousands, Except Share and Par Value Amounts; Unaudited)

December 31, 2012 2011


8,007 137 348 8,492 142 8,634

22,477 99 317 22,893 216 2 23,111

525 1,074 1,106 492 3,197 770 3,967

1,331 2,592 7,000 553 11,476 1,224 52 12,752

15 328,097 (323,445) 4,667 $ 8,634

15 326,796 (316,299) (153) 10,359 $ 23,111


Historical Financial Information

Revenue: Product License Total revenue Cost of revenue: Product Total cost of revenue Gross profit Operating expenses: Research and development(1) Sales and marketing(2) General and administrative Total operating expenses Loss from Operations Interest income Interest expense Gain on sale of instrument business Gain on litigation settlement, net Change in fair value of warrants Reorganization items Other expense, net Loss before income taxes Income tax benefit (expense) Net loss Loss per share - basic and diluted Weighted average common shares used to compute basic and diluted net loss per common share Non-cash stock-based compensation expense included in operating expenses: (1) Research and development (2) Sales and marketing (3) General and administrative $ 28 55 413 $ $ $

(Amounts in Thousands, Except Share and Per Share Amounts; Unaudited)

Three months ended December 31, 2012 2011 $ 1,029 113 1,142 32 32 1,110 333 931 1,127 2,391 (1,281) 5 (9) (90) (1,375) (1,375) (0.09) 15,124,012 $ $ $ 755 113 868 24 24 844 1,168 1,219 1,527 3,914 (3,070) 9 (66) 4 (22) 10 (3,135) (3,135) (0.21) 14,866,848 $ $ $

Year Ended December 31, 2012 2011 1,640 454 2,094 131 131 1,963 2,216 4,653 4,508 11,377 (9,414) 28 (206) 1,830 710 88 (182) (7,146) (7,146) (0.48) 15,010,868 $ $ $ 1,469 454 1,923 129 129 1,794 5,387 5,539 8,509 19,435 (17,641) 64 (396) 378 (96) (99) (17,790) (17,790) (1.25) 14,249,570

96 36 182

127 203 965

686 158 2,446


Renowned Clinical Partnerships Set the Stage for Success(1)


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


Estimated. Expected milestones are not placed in any specific order within years.




Why it works: OVA1 Score Correlates with Probability of Malignancy4


Research has shown that as the OVA1 score increases, there is an increasing probability of ovarian malignancy

Percent of Elevated OVA1 Score Having Malignancy

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


Validated Through 44 Clinical Sites4,6,7


Two prospective clinical trials >1,000 adnexal surgeries >250 various malignancies 3 separate publications

Study 1 sites: Study 2 sites :

17 17

Study 1 & 2 sites:



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


Comparison with ROMA Algorithm

Risk Stratification Sensitivity of OVA14 & ROMA8
98% 75% 100% 100% 84% 66% 93%



Early Stage OVA1 (n=) ROMA (n=) 39/40 9/12

Late Stage 52/52 36/36

Non EOC 57/68 27/41

All Cancers Studied 149/161 72/89

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%

4. Ueland FR, DeSimone CP, Seamon LG, et al. Obstet Gynecol. 2011;117(6):1289-1297 8. ROMA (HE4 EIA + Architect CA125 II) Instructions For Use, 2011 -09, Fujirebio Diagnostics, Inc.


New AMA CPT Code a Watershed Industry Milestone

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 peerreviewed 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


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.


Quest Diagnostics Alliance


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
Est. Market, Annual Tests Reference Labs Physician Offices Hospital Labs Current OVA1 Sales





Untapped market




Summary of Vermillion's Diagnostic Patent Portfolio

Disease Area Ovarian cancer Breast cancer Alzheimer's disease Patents Granted U.S. 5 1 3 Non-U.S. 27 1 6 Total 32 2 9


Families 14 3 3


11 26

10 46

21 72

8 32

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


Vascular Medicine Program

Risk Assessment for Peripheral Artery Disease (PAD)

PAD Unmet Need & Market Opportunity


10 million people with PAD in the U.S. many undiagnosed 11

What is Peripheral Artery Disease?

Normal Artery

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
At Risk Group14 Diabetics aged 50+ Smokers aged 50+ Elderly aged 65+ Group Overlap

PAD-Inflicted Artery (atherosclerotic)

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

U.S. Population

13 20 38 (12) 59 Million

Total At-Risk Population

Positive Results from PAD Intended Use Study


PAD study results published in Vascular Medicine, Oct. 2012

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 conventional clinical assessment alone

Results were published in the prestigious peerreviewed journal, Vascular Medicine15

Currently seeking strategic partner(s) to further PAD development & commercialization
Results indicate this biomarker model is a useful adjunctive tool that adds independent value to a clinical risk score in the target population of low to moderate Framingham risk.

15. Hiatt W, et al, A Validated Biomarker Panel To Identify Peripheral Artery Disease Vasc Med December 2012 vol. 17 no. 6 386-393