interpace diagnostics investor presentation
TRANSCRIPT
January 2017
Investor Presentation
IDXG
Forward Looking Statements
2
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 our control. These statements also involve known and unknown risks, uncertainties and other factors that may cause our 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, our ability to restructure our debt and other obligations, 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 our Prospectus Supplement and our 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 30, 2016, as amended on April 29, 2016 and June 14, 2016, and in the company’s Form 10-Q filed with the SEC on November 17, 2016. 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 Investor Presentation and, except as may be required by law, we undertake no obligation to revise or update publicly any forward-looking statements for any reason.
• 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 ABGenomics Int’l, SVP Finance and Administration & Corporate Secretary at SynaGeva BioPharma as well as an interim CFO and BD services consultant to the medtech industry.
Management Team
3
Our Mission
4
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.
Overview & Key Accomplishments
NASDAQ listed company offering high-margin pre-cancerous diagnosis and prognosis tests
Growing revenues in proprietary, high-value space
4 proprietary offerings in two key verticals (Endo & GI)— 3 products now covered by Medicare across multiple regions
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
AETNA insurance reimbursement for ThyraMir announced in Q4
Corporate restructuring continuing 5
Powered by PathFinderTG®
Our Marketed Molecular Tests
Estimated Current U.S. Market OpportunityPancreatic Cysts
$350MThyroid Nodules
$350M
GastrointestinaI Endocrine
Source: JAMA, 2012; Archives of Internal Medicine 20096
Pancreatic CystsCancer Risk
Powered by PathFinderTG®
7
The Fourth Leading U.S. Cancer Killer
Cervix Ovary Prostate Pancreas Breast Colorec-tal
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 com-
mon cancers
Pancreatic Cancer
8
Leukemia Pancreatic Colon
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%
7%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 pts 9
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 disease3
Unnecessary healthcare costs High morbidity (30%) and mortality (2%)2
associated with these surgeries– Pancreatic cancers go undetected
Pancreatic cysts:
2-5%risk of cancer increasing with age1
Pancreatic cysts:
80%surgeries are benign
Source: 1Gastroenterology Research and Practice Volume 2012, Article 147465 2Gastroenterology 2015; 148:819-8223http://www.seenamagowitzfoundation.org/pancreatic-cysts/ 10
The Endocrine Oncology
11
12
Common clinical problem
~10-18 mUS Adults have nodules
Estimated
525,000thyroid FNA per year in US and growing
Thyroid Cancer Incidence*
*American Cancer Societyhttp://www.cancernetwork.com/thyroid-cancer/thyroid-nodules-when-biopsy
Thyroid Nodules
ThyraMIR™ Thyroid miRNA Classifier
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
+
13
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
14
Yield of Molecular Reclassification
• 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)
+
15
Barrett’s EsophagusRisk of progression to cancer
Powered by PathFinderTG®
16
~850,000 Endoscopic screens
Annually
$2B Potential
Same PathfinderTG® platformBarreGen™ clinical experience program
launched September 1st, 2016
~3.3M Adults
BarreGen for Barrett’s Esophagus
17Source: Indications and Outcomes of Gastrointestinal Endoscopy, 2009
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 personalized 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
18
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 (Our Base Study)
Reprinted from Eluri et al. Am J Gastroenterol 2015; 110:828–834; doi: 10.1038/ajg.2015.152 19
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 required Establish collaborations with Barrett’s Center of Excellence Excellent partnering opportunity
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
20
Patent Portfolio and Proprietary Attributes
21
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). One on the diagnosis, determination of malignant potential and biological potential of pancreatic cysts. One on 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.
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
22
Medicare ; 3%Medicare Ad-van-tage; 9%
Commercial; 52%
Client Billing; 30%
Others; 6%
Thyroid
GI Endocrine
Billing & Reimbursement Overview
23
List Price $4,000
Averaged Realized Revenue
$2,600
Now Billed Under Molecular Code
81479
Covered Lives +71 million
List Price $1,675 $4,000
Averaged Realized Revenue $1,100 $2,000
Now Billed Under Molecular Code 81445 81479
Covered Lives +200 million +200 million
Source: Cooper DS et al. Thyroid. 2009;19(11):1167-1214; National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Thyroid Carcinoma. V.1.2014; ATA Guidelines on Thyroid Nodules and Differentiated Thyroid Cancer – Highlights, Consensus, and Controversies. ICE/ENDO conference; June 21-24, 2014; Chicago, Illinois.
2014 American Thyroid Association Revised Guidelines MDx Tests should be considered for suspicion of malignancy or indeterminate.
2013 NCCN Guidelines Molecular Diagnostics recommended testing on some indeterminate cytologies to minimize unnecessary surgeries
Guideline Recommendations
24
PancraGen™ establishes a new standard for the prognosis and diagnosis of pancreatic cysts
Current Pancreatic Cysts Guidelines Sendai guidelines 2012 and ACG guidelines 2007 strongly favor surgical resection because of the inability of first-line tests to predict biological behavior and aggressiveness.
GASTROINTESTIONAL(GI) PRODUCTS Launched new Biliary product October 3rd, 2016 Launched AccuCEA™ Insights August 1st, 2016 Launched PanDNA™ September 1st, 2016 Launched BarreGen® Clinical Experience
Program September 1st, 2016ENDOCRINE PRODUCTS Launched Cytopathology Services October 1st,
2016 Launched Cytology Slides as primary specimen
October 1st, 2016
Recent Product Developments
Income Statement
2016 2015 2016 2015
Revenue, net 3,316$ 2,506$ 9,963$ 6,876$ Cost of revenue 1,846 1,799 4,866 5,224
Gross Profit 1,470 707 5,097 1,652
Sales and marketing 1,282 2,876 4,186 8,387 Research and development 659 1,000 1,339 1,646 General and administrative 2,858 2,498 7,655 8,909 Acquisition related amortization expense 970 986 2,909 2,825 Asset impairment 3,363 - 3,363 - Change in fair value of contingent consideration (1,174) - (1,174) -
Total operating expenses 7,958 7,360 18,278 21,767
Operating loss (6,488) (6,653) (13,181) (20,115) Interest expense (539) (884) (1,601) (2,616) Other income (expense), net 4 (112) 14 (268)
Loss from continuing operations before tax (7,023) (7,649) (14,768) (22,999) Income tax expense (benefit) 173 (180) (54) (430)
Loss from continuing operations (7,196) (7,469) (14,714) (22,569) (Loss) income from discontinued operations, net of tax (297) 2,574 101 6,828
Net loss (7,493)$ (4,895)$ (14,613)$ (15,741)$
Basic and diluted income (loss) per share of common stock:From continuing operations (0.40)$ (0.48)$ (0.82)$ (1.48)$ From discontinued operations (0.02) 0.16 0.01 0.45
Net loss per basic and diluted share of common stock (0.41)$ (0.31)$ (0.81)$ (1.03)$
Weighted average number of common shares andcommon share equivalents outstanding:
Basic and Diluted 18,163 15,654 18,029 15,301
(in thousands, except per share data)
September 30,Three Months Ended Nine Months Ended
September 30,
Other Select Financial Information
September 30, December 31, 2016 2015
Cash and cash equivalents 1,693$ 8,310$
Total current assets 6,683 19,165 Total current liabilities 19,870 23,373
Total assets 45,964 67,712 Total liabilities 47,443 54,674 Total stockholders' (deficit) equity (1,479) 13,038
Selected Cash Flow Data($ in thousands)
2016 2015Net loss (14,613)$ (15,741)$
Net cash used in operations (6,617)$ (13,536)$ Net cash used in investing activities - (583) Net cash used in financing activities - (37) Change in cash and cash equivalents (6,617) (14,156) Cash and equivalents, Beginning 8,310 23,111 Cash and equivalents, Ending 1,693$ 8,955$
For the Nine Months Ended
Selected Balance Sheet Data($ in thousands)
September 30,
Thank you
IDXG