idxg corporate presentation global online growth conference - oct 2016

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October 2016 Corporate Presentation IDXG

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Page 1: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

October 2016

Corporate Presentation

IDXG

Page 2: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

This presentation contains forward-looking statements within the meaning of Section

27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of

1934 and the Private Securities Litigation Reform Act of 1995, relating to our future

financial and operating performance. The company has attempted to identify forward

looking statements by terminology including "believes," "estimates," "anticipates,"

"expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will,"

"should," "approximately" or other words that convey uncertainty of future events or

outcomes to identify these forward-looking statements. These statements are based

on current expectations, assumptions and uncertainties involving judgments about,

among other things, future economic, competitive and market conditions and future

business decisions, all of which are difficult or impossible to predict accurately and

many of which are beyond company’s control. These statements also involve known

and unknown risks, uncertainties and other factors that may cause company’s actual

results to be materially different from those expressed or implied by any forward-

looking statement. Known and unknown risks, uncertainties and other factors include,

but are not limited to, our ability to adequately finance the business, the market's

acceptance of our molecular diagnostic tests; our ability to secure additional business

and generate higher profit margins through sales of our molecular diagnostic tests, in-

licensing or other means, projections of future revenues, growth, gross profit and

anticipated internal rate of return on investments. Additionally, all forward-looking

statements are subject to the risk factors detailed from time to time in the company’s

periodic filings with the Securities and Exchange Commission (SEC), including

without limitation, the Annual Report on Form 10-K filed with the SEC on March 5,

2015 and in the company’s Form 10-Q filed with the SEC on November 12, 2015.

Because of these and other risks, uncertainties and assumptions, undue reliance

should not be placed on these forward-looking statements. In addition, these

statements speak only as of the date of this press release and, except as may be

required by law, the company undertakes no obligation to revise or update publicly

any forward-looking statements for any reason.

FORWARD-LOOKING STATEMENTS

In addition to the United States generally accepted accounting principles (GAAP)

results, we disclose certain non-GAAP financial measures. A “non-GAAP financial

measure” is defined as a numerical measure of a company’s historical or future

financial performance, financial position or cash flows that excludes (or includes)

amounts, or is subject to adjustments that have the effect of excluding (or

including) amounts, that are included in (or excluded from) the most directly

comparable measure calculated and presented in accordance with GAAP in a

company’s financial statements. Management does not intend the presentation of

non-GAAP financial measures to be considered in isolation or as a substitute for

results prepared in accordance with GAAP.

Management believes that this non-GAAP financial measure, when presented in

conjunction with comparable GAAP financial measure, is useful to both

management and investors in analyzing our ongoing business and operating

performance. Management believes that providing non-GAAP information to

investors, in addition to the GAAP presentation, allows investors to view our

financial results in the way that management views financial results.

In this document, we discuss Adjusted Operating Loss, a non-GAAP financial

measure defined as operating loss from continuing operations excluding

amortization expense of acquisition related intangible assets and other fair value

adjustments. A reconciliation of this non-GAAP financial measure to its most

directly comparable GAAP financial measure is presented in the table attached to

the earnings release issued on November 12, 2015 and posted on the company’s

website investor section.

NON-GAAP FINANCIAL MEASURES

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Page 3: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Our Mission

We provide clinically useful molecular

diagnostic tests and pathology

services for evaluating risk of cancer

by leveraging the latest technology in

personalized medicine for better

patient diagnosis and management.

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Page 4: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Brief History

• PDI founded by Pat Dugan in 1988 who today still owns approximately 30%

• Previously a standalone, publically held, CSO business:

• attained a market cap of nearly $2 billion in December of 2000 focused on

leveraging its commercial resources on its own Rx products

• Acquired the assets of Asuragen for thyroid and endocrine cancer for $9 million and

upgraded to an NGS platform in August 2014

• Acquired RedPath for Pancreatic and GI cancers for $24 million in October 2014

• Sold the Commercial Services (CSO) business of PDI in December 2015 for $28.5

million; repaid debt and provided working capital

• Two state of the art CLIA-certified labs. Largest in Pittsburgh. Headquarters in NJ

• Additional pipeline tests include an assay for Barrett’s esophagus and biliary—both

launching in Q4 2016

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Page 5: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Overview & Key Accomplishments

NASDAQ listed company offering high-margin pre-cancerous diagnosis and prognosis tests

Rapidly growing revenues (60% y-o-y) and test volumes in proprietary, high-value space

4 proprietary offerings in two key verticals (Endo & GI)—Medicare reimbursement already secured for 3 products at highly attractive prices

High barriers to entry due to reimbursement, complexity of tests and intellectual know how

Cash collections expanding—$3.3 million in Q2 alone

Achieved New York State approval in Q3 2016—should yield an incremental 15%

Corporate restructuring continuing

Page 6: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Powered by PathFinderTG®

Our Marketed Molecular Tests

Current U.S. Market Opportunity

Pancreatic Cysts

$350MThyroid Nodules

$350M

GastrointestionaI Endocrine

Source: Company estimates6

Page 7: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Pancreatic CystsCancer Risk

Powered by PathFinderTG®

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Page 8: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

The Fourth Leading U.S. Cancer Killer

Cervix Prostate Breast Lung

45,000new U.S. cases

39,590U.S. deaths 4,020

14,270

29,480

39,590 40,430

50,310

159,260

Source: ACS Cancer Facts & Figures 2014; all figures annual

5-year survival rate 7.2%

Pancreatic cancer 3% of new cancer cases in US, 12% of deaths of common cancers

Pancreatic Cancer

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Page 9: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

PancraGEN™ (formerly PathfinderTG®)

Imaging Cytology Fluid Analysis (CEA , Amylase)

Molecular Diagnostics

Pathologist Review

• DNA quantity & quality

• Oncogene point mutations (KRAS, GNAS)

• Loss of heterozygosity (LOH) 25 markers measured

• Detailed quantitative molecular profiling integrated with first-line clinical findings leading to risk assessment and clear, management recommendations

PancraGEN – Integrated Molecular Pathology

34%

8%

52%

6%

CEA above 1000 ng/ul with High EUS

Benign

Statistically Indolent

Statistically Higher Risk

Aggressive

+

Virtual risk assessment using 13,000+ testing & 492 cyst registry pts9

Page 10: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

120,000 Pancreatic Cysts Annually

• The clinical dilemma:– Current guideline tests are unreliable and

poorly predict cancer risk

Cyst fluid tested for CEA, amylase, and

cytology (1st line tests)

• The result:– 80% of all surgeries are for benign disease

Unnecessary healthcare costs

High morbidity (30%) and mortality (2%)2

associated with these surgeries

– Pancreatic cancers go undetected

Pancreatic cysts:

2-5%risk of cancerincreasing with age1

Pancreatic cysts:

80%surgeries are benign

Source: 1Gastroenterology Research and Practice Volume 2012, Article 1474652Gastroenterology 2015; 148:819-822

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Page 11: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

The Endocrine Oncology

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Page 12: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

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Common clinical problem

~10-18 mUS Adults have nodules

Estimated

525,000thyroid FNA per year in US and growing

Thyroid Cancer Incidence*

*American Cancer Society

Thyroid Nodules

Page 13: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

First microRNA gene expression classifier

ThyraMIR™ measures the expression of 10 microRNAs and,

when used in combination with ThyGenX™, yields both high

NPV and high PPV

ThyGenX™ and ThyraMIR™ combination testing can accurately “Rule in” and “Rule out” the risk of malignancy

ThyGenX™ and ThyraMIR™ combination testing addresses

a unmet clinical need for more actionable information in

the management of indeterminate thyroid nodules

+

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Page 14: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Yield of Molecular Reclassification

Cancer prevalence: 32%

38% “benign”

with 93% NPV

62% “suspicious”

with 47% PPV

SurgeryFollow

Afirma

Avoidable surgeries: 68% 33%

Indeterminate diagnosis

Combination testing provides accurate molecular reclassification without surgery

• 85% (6.7-fold) decrease in unnecessary surgeries (from 68% to 10%)

• 69% (3.3-fold) decrease in unnecessary surgeries relative to Afirma (from 33% to 10%)

• 65% (1.65-fold) increase in true benign yield relative to Afirma (from 35% to 58%)

•Pts with benign disease avoid surgery, 75% pts with cancer proceed directly to total thyroidectomy (red)

Surgery

68% benign outcome

Indeterminate diagnosis

61% “benign”

with 94% NPV

39% “malignant”

with 74% PPV

Combination testing

SurgeryFollow

10%

Indeterminate diagnosis

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Page 15: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

• Combined test performance results in a 94% likelihood that a negative result is truly benign and a 74% likelihood that a positive result is malignant (based on a prevalence of 32%)

• The 74% likelihood of a positive result being malignant is a vast improvement over the “50/50” likelihood of the Afirma’s suspicious call

• The benign call rate for ThyGenX/ThyraMIR is SUPERIOR to Afirma®—allowing up to 65% more patients to consider a watchful waiting approach

ThyGenX™ / ThyraMIR™ Summary

The end result is a 69% decrease in unnecessary surgeries

relative to the Afirma test. (Labourier et al., JCEM 2015)

+

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Page 16: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Barrett’s Esophagus

Risk of progression to cancer

Powered by PathFinderTG®

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Page 17: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

~850,000 Endoscopic screens

Annually

$2B Potential

Same PathfinderTG® platform

BarreGen™ commercial launch expected in 2016

~3.3M Adults

Source: Company estimates

BarreGen for Barrett’s Esophagus

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Page 18: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

How may BarreGEN be useful?

• Current surveillance methods based on histology are inadequate at assessing risk of disease progression to HGD/EAC

• BarreGEN may help differentiate patients a low risk of EAC from high risk of EAC prior to visible HGD/EAC morphology

• BarreGEN can allow for more personalize management of Barrett’s patients including:

• Aid in strategies to prevent cancer (ablation)

• Avoid unnecessary ablative therapy

• Help monitor patients during surveillance

• Reduce healthcare costs

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Page 19: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Results:

• The mean ML in pre-progression biopsies was higher in progressors (2.21) than

nonprogressors (0.42; p<0.0001)

• BarreGEN had a high overall accuracy for predicting progression to cancer (ROC

curve AUC = 0.95, 95% CI 0.89-1), with all loci contributing to this performance

• Prior to progression, accuracy of BarreGEN was highest (90%) at an ML of 1, where

optimal sensitivity (96%) and specificity (87%) were achieved.

Eluri et al 2015

Reprinted from Eluri et al. Am J Gastroenterol 2015; 110:828–834; doi: 10.1038/ajg.2015.15219

Page 20: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Soft launch initiated in H2 2016

Prognostic value in determining cancer progression risk

BASE study Eluri 20151 (n=69)

Diagnostic value in detecting true dysplasia (HGD) in BE

Ellsworth 2012 study2 (n=271) and Khara 2014 study3 (n=415)

Additional clinical studies underway

Establish collaborations with Barrett’s Center of Excellence

1 Eluri et al. Am J Gastroenterology 2015, 110:828-8342 Ellsworth et al. BMC Gastroenterology 2012, 12:1813 Khara et al. J. Gastrointestinal Cancer 2014 DOI 10.1007/s12029-013-9570-y

BarreGen™ - Multi-stage Introduction

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Page 21: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Patent Portfolio and Proprietary Attributes

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Thyroid: 9 patents pending- Seven patents on microRNAs as biological markers for distinguishing benign from malignant thyroid neoplasm. One patent on microRNAs as diagnostic biomarkers to distinguish benign from malignant thyroid nodules. One patent on the combination ThyGenX/ThyraMIR assay to classify thyroid nodules.

Pancreas: 3 patents- One on the platform for obtaining molecular information from clinical specimens and integrating with clinical information (Topographic Genotyping, issued 2001). Oneon the diagnosis, determination of malignant potential and biological potential of pancreatic cysts. One on the an improved method for determination of pancreatic cyst fluid CEA levels.

Barrett’s esophagus: Two patents pending- Use of mutational load to assess likelihood of progression of Barrett’s esophagus and corresponding need for treatment.

Proprietary attributes: Extensive experience in managing extremely low quality, fixative treated clinical specimens. Lab information management system that extracts results from database and allows efficient integration of molecular and clinical results. Analysis of DNA, mRNA and microRNA from fresh, cytology and paraffin embedded samples including residual material contained cell-free nucleic.

Page 22: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

new U.S. cases

39,590U.S. deaths

Medicare , 35%

Medicare Advantage,

19%

Commercial, 29%

Client Billing, 11%

Others, 6%

PancraGen*

*Payer mix % based on claim submissions; May vary by month

PancraGen and Thryoid Tests - Payor Type Mix

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Medicare , 3%

Medicare Advantage,

9%

Commercial, 52%

Client Billing, 30%

Others, 6%

Thyroid

Page 23: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

GI Endocrine

Billing & Reimbursement Overview

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List Price $4,000

Averaged Realized

Revenue$2,600

Medicare $3,100

Now Billed Under

Molecular Code81479

Covered Lives +71 million

List Price $1,675 $4,000

Averaged Realized

Revenue$1,100 $2,000

Medicare $1,057 $2,200

Now Billed Under

Molecular Code81445 81479

Covered Lives +148 million +67 million

Page 24: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Billing & Reimbursement Overview

Managed Care Coverage and Contracts

CONFIDENTIAL INFORMATION - DO NOT DISTRIBUTE

Health Plan NameNumber of

LivesPancraGen ThyGenX ThyraMIR

Medical Policy

CoverageContract Pricing

Aetna 22,000,000

Cigna 16,000,000

United 34,000,000

CareFirst BCBS 3,340,000

Choice Care Network (Humana) 6,600,000 $3,101 PancraGen

Humana Military (TriCare South) 3,000,000 TMAC

Geisinger Health Plan 500,000 Pending Pending $3,600 PancraGen

Kaiser 9,000,000 $795 (ThyG)/$2,800 (ThyM)

Highmark BCBS 5,930,000 $3,658 PancraGen

ACPN (Network) NA $3,200 PancraGen, $1,340

(ThyG), $3,200 (ThyM)

Fed Med (Network) NA $3,200 PancraGen

Provider Select Network NA $3,798 PancraGen

Ohio State Health Plan 58,000 $3,800 PancraGen

Multi Plan NA $3,200 PancraGen

MagnaCare $3,600 PancraGen

lnterwest Health $3,400 PancraGen

HealthSmart (Network) $3,200 PancraGen

Fortified Provider Network (FPN) $3,798 PancraGen

Emblem Health 3,400,000

Harvard Pilgrim 1,000,000

Medicare (1)

(Novitas-Solutions) 55,200,000 $3,101 PancraGen

Number of Lives Covered 187,628,000 71,288,000 148,870,000 67,540,000

(1) Medicare numbers will overlap some health plan populations above, since the total lives in the heatlh plans include some medicare lives

along with commercial lives.

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Page 25: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Source: Cooper DS et al. Thyroid. 2009;19(11):1167-1214; National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Thyroid

Carcinoma. V.1.2014; ATA Guidelines on Thyroid Nodules and Differentiated Thyroid Cancer – Highlights, Consensus, and Controversies. ICE/ENDO conference;

June 21-24, 2014; Chicago, Illinois.

2014 American Thyroid Association Revised Guidelines

MDx Tests should be considered for suspicion of malignancy or indeterminate.

2013 NCCN Guidelines

Molecular Diagnostics recommended testing on some indeterminate cytologies to minimize unnecessary surgeries

Guideline Recommendations

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PancraGen™ establishes a new standard for the prognosis and diagnosis of

pancreatic cysts

Current Pancreatic Cysts Guidelines

Sendai guidelines 2012 and ACG guidelines 2007 strongly favor surgical resection because of the inability of first-line tests to predict biological behavior and aggressiveness.

Page 26: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Operations & Financials

IDXG

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Page 27: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

GASTROINTESTIONAL(GI) PRODUCTS

Launched new Biliary product October 3rd, 2016

Launched AccuCEA™ Insights August 1st, 201

Launched PanDNA™ September 1st, 2016

Launched BarreGen® Clinical Experience Program September 1st, 2016

ENDOCRINE PRODUCTS

Launched Cytopathology Services October 1st, 2016

Launched Cytology Slides as primary specimen October 1st, 2016

New York State approval of ThyGenX September 30th, 2016

New Development

Page 28: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Team Bios

• Jack E. Stover President & CEO since December 2015. Prior Director of PDI. Director of Onconova Therapeutics and Viatar CTC. Previously President & CEO of Antares Pharma and COO of Sicor Inc and CFO/COO of Gynetics Inc. and Partner at PWC

• Sydney Finkelstein MD, CMO and CSO, Founder of RedPath. A board certified anatomic pathologist with extensive experience and accomplishments in academic surgical pathology and molecular pathology. Formerly Professor of Pathology at the Univ. Pittsburgh. Syd has authored over 200 peer review manuscripts and is a nationally recognized authority in Gastrointestinal Pathology and Solid Tissue molecular diagnostics.

• Greg Richard Sr. VP Commercial Services. Previously at Aetna and moved to Genentech as Director of managed care. VP of Managed Care for Quest and Sr. VP of Sales for LabCorp and a frequent speaker at lab industry conferences

• Jim Early Chief Financial Officer. Previously CFO at both ABGenomics Int’l and SanGeva BioPharma as well as an interim CFO and BD services consultant to the medtech industry.

Page 29: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Week 39

YTD GI MDx Orders (actual vs planned)

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Page 30: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Week 39

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Page 31: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

Investment Considerations

• Interpace is a NASDAC listed company

• Strong management team and over ten years of experience

• Good and growing reimbursement in place in high value-added

molecular space

• Significant revenue growth in 2016

• Expansion product launches underway

• Pipeline of products already developed in large market opportunity

• Monthly cash collections in excess of $1 million and growing

• Lowest trading price in history due to transition “overhang” from

previous CSO business

• Multiples in the MDX space often 2 to 4 X revenues

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Page 32: Idxg Corporate Presentation Global Online Growth Conference - Oct 2016

THANK YOU!

IDXG

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