NASDAQ CM | IDXG (Common Stock)
Interpace Diagnostics Group, Inc., formerly PDI, Inc. is a molecular diagnostics development and commercialization company.
Morris Corporate Center 1, Building A
300 Interpace Parkway
Parsippany, NJ 07054
Authorized Shares: 100,000,000 shares
Outstanding shares: 18,162,671 shares (as of Aug 5, 2016) (hasn't changed since early 2016)
Current Book Value: $0.339 / share
Projected 2016 Revenue per share: on track for .61~.80/share (based on Q1/Q2 reports)
John P. Dugan: 4,869,878 common shares
other insiders: approx 2,672,149 shares collectively
total insiders: 7,542,027 shares
Institutional Ownership: 30.6% (5.5 mil shares)
largest institutional holder:
Heartland Advisors: 2,994,313
Publically traded float: 10,620,644 shares
if including institutional holders, Float = 5,120,644 Investment Highlights:
Interpace Diagnostics (IDX) was formerly part of PDI that had both IDX and Commercial Services (CSO) businesses. PDI was renamed Interpace Diagnostics Group after the sale of CSO in December 2015
•Focused on developing and marketing molecular based diagnostic tests in high value precision pre-cancerous test markets
•Three proprietary cancer molecular tests on the market in GI and Endocrine
•PancraGenTM–The new standard of pancreatic cyst diagnostics
•ThyGenXTMand ThyraMIRTM-Next-Gen sequencing oncogene panel and miRNAclassifier in combination to improve risk classification of Thyroid nodules
•Two state of the art CLIA-certified labs
•Additional pipeline tests under development including BarreGenTMfor Barrett’s Esophagus, an esophageal cancer risk classifier
•Addressable potential market opportunity of $2.7 billion with all four tests
•Revenue of approximately $10 million in 2015, supported by IDX sales forces
•Focus for 2016: Grow recently launched ThyGenX/ThyraMIRtests and expand PancraGenmarket penetration
AUGUST2014:Acquired ThyroidAssetsfrom Asuragen
OCTOBER2014: Acquired RedPathInc., GI assetsand CLIA lab
DECEMBER2014: Launched ThyGenX™NextGen Sequencing Thyroid Cancer Test
FEBRUARY2015: Published landmark study on PancraGen™in Endoscopy
APRIL2015: Launched ThyraMIR™microRNA Gene Expression Thyroid Cancer Test
MAY2015: Published the major clinical validation study in JCEM for combining ThyGenXand ThyraMIRin a single testing service
MAY2015: Published BarreGen™BASE study on Barrett’s Esophagus cancer risk progression in AJG
AUGUST2015: Covered lives for Interpace Diagnostics products exceeded 100 million for all tests combined
OCTOBER2015: Data presented at ACG demonstrate that PancraGen™can improve detection of malignant or highly aggressive pancreatic cysts over current guidelines criteria, and improve patient outcomes in real life management decisions
New data presented at ATA further validates the power of combination testing by ThyGenX™and ThyraMIR™, improving the preoperative diagnosis of thyroid nodules with indeterminate cytology
DECEMBER2015: PDI transformed into Interpace Diagnostics Group through the sale of its CSO business to focus exclusively on molecular diagnostics
High Value Molecular Pre-Cancerous Test Market:
Jack Stover, Interim President and CEO
Mr. Stover has been Chief Executive Officer of Zebec Therapeutics LLC (“Zebec”) since April 2014. Zebec is the successor to Quadrant Pharmaceuticals LLC, which Mr. Stover co-founded and was President and Director of from September 2013. Mr. Stover has been a Director and Chairman of the Audit Committee of PDI, Inc., a public company since 2005. From 2009 to February 2012, Mr. Stover served as the executive chairman of Targeted Nano Therapeutics LLC, a privately held biotechnology company focused on targeted delivery of peptides and proteins. Mr. Stover was also chairman of the audit committee and a member of the board of directors of Arbios Systems Inc. from 2005 to 2008 and a member of the board of directors of Influmedix, Inc. from 2010 to 2011.
From 2004 to 2008, he served as chief executive officer, president and director of Antares Pharma, Inc., a publicly held specialty pharmaceutical company listed on the American Stock Exchange. Prior to that, Mr. Stover was executive vice president and chief financial officer of Sicor, Inc., a publicly held company which manufactured and marketed injectable pharmaceutical products, and which was acquired by Teva Pharmaceutical Industries. Prior to that, Mr. Stover was executive vice president and director of a proprietary women’s pharmaceutical company, Gynetics, Inc. (“Gynetics”), and before Gynetics, he was senior vice president and director of B. Braun Medical, Inc., a private global medical device and pharmaceutical company. For more than five years prior to that, Mr. Stover was a partner with PricewaterhouseCoopers (then Coopers and Lybrand), working in the lifesciences industry division. Mr. Stover received his B.A. in Accounting from Lehigh University and is a Certified Public Accountant.
Greg Richard, SVP Commercial Services
Greg Richard, Sr. Vice President of PDI, Inc. and SVP of Commercial Services at Interpace Diagnostics, has been in the healthcare business for over 25 years in various industries including managed care, biotech pharmaceuticals, CRO services, and diagnostics. He started his career in sales at Aetna and moved to Genentech as the Director of Managed Care. He transitioned in to the diagnostics industry as the Vice President of Managed Care for Quest Diagnostics and served in this role for 8 years. Greg also led the international clinical trials sales team while at Quest. Following his tenure at Quest, Greg worked for several privately held companies including CRO’s, molecular diagnostics, and anatomic pathology services providers. He also served as the Sr. Vice President of Sales for the Northeast Division of LabCorp. Greg is a certified Six Sigma Green Belt and frequent speaker at healthcare industry conferences such as the G2 Lab Institute and the NextGen Dx Summit.
Syd Finkelstein, Chief Scientific Officer
Dr. Finkelstein is a board certified pathologist specializing in gastrointestinal pathology with extensive experience in molecular diagnostics. He is the Adjunct Professor of Pathology, Drexel University on the faculty of Allegheny General Hospital, Pittsburgh, PA. He serves as Adjunct Professor at Temple University. He is the founder of RedPath Integrated Pathology, which was acquired by Interpace Diagnostics in 2014. In this position, Dr. Finkelstein is applying clinical translational research of molecular genetic discoveries to standard surgical pathology practice a goal to which he has dedicated his entire career. He spent 20 years as a practicing academic surgical pathologist, holding appointments as associate and then full professor at the University of Pittsburgh and at Hahnemann University in Philadelphia. In 1990, he began work on the development of Topographic Genotyping, his patented technology for enhancing polymerase chain reaction amplifiability of minute, microdissected, fixative treated tissue samples. Dr. Finkelstein is a nationally recognized expert in both Gastrointestinal Pathology and Solid Tissue Molecular Pathology.
James E. Early, Interim CFO
Mr. Early, age 62, previously served as the Interim and subsequently permanent Chief Financial Officer of AbGenomics International Inc., a clinical stage drug development company with a product pipeline in immunology and oncology, from September 2015 to July 2016. Mr. Early also previously served as the Chief Financial Officer of Zebec Therapeutics, LLC from October 2014 to September 2015. In addition, Mr. Early has provided interim chief financial officer and business development services for pharmaceutical, life science and other similar companies as a sole proprietor from August 2009 to December 2013 and through Early Financial Consulting, LLC from January 2014 to the present. Mr. Early is a Certified Public Accountant and has an MBA in Finance and Accounting.
Summary of Early's CFO services:
- Strategic Planning
Deal Procurement and Contract Negotiations
Capitalization and Long-Term Financing
Private Equity Modeling
IRC 409A and FAS 123R Share Payment/Stock Option Valuation Support
Current Marketed Products:
BarreGen is a Molecular diagnostic test to determine the risk of progressing to esophageal cancer in patients with Barrett’s Esophagus
- While only about 0.5% of Barrett's esophagus patients will develop esophageal cancer, the 5-year survival rate of esophageal cancer ranges from 4% to 40%.
BarreGen utilizes an assay that assesses loss of heterozygosity and genetic mutations of multiple tumor-suppressor genes.
A longitudinal study shows the BarreGen test had an overall accuracy of 95% in identifying patients who progressed to cancer from those who did not.
PancraGEN® is a unique, DNA-based pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, can aid in pancreatic cancer risk assessment. PancraGEN® is 90% accurate, according to clinical studies, enabling effective risk stratification of patients. Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths.
Long-term follow-up outcomes data of patients (up to 8 years) from the National Pancreatic Cyst Registry supports PancraGEN’s ability to help accurately inform surgery and surveillance decisions of patients.
In a study of the National Pancreatic Cyst Registry, PancraGEN’s recommendation of surveillance was correct in 97% of patients. In fact, PancraGEN diagnoses were more beneficial to overall patient outcomes than sole reliance on International Consensus Guidelines (ICG) criteria.
PancraGEN has been performed on over 25,000 patients with pancreatic cysts, representing a full spectrum of pancreatic cyst patients with diverse clinical and molecular findings.
Medical Publications proving benefits of PancraGen:
ThyGenX® Thyroid Oncogene Panel and ThyraMIR™ Thyroid miRNA Classifier molecular testing that aids in the diagnosis of thyroid nodules by identifying genetic alterations associated with thyroid cancer. ThyGenX® and ThyraMIR™ combination testing helps to better assess the risk of thyroid nodules being either benign or malignant—and helps reduce unnecessary surgeries.
ThyGenX® is a highly specific oncogene (mutational) panel that assesses the most common genetic alterations across 8 genes associated with papillary carcinoma and follicular carcinoma.
ThyraMIR™ is the first and only miRNA gene expression classifier, and is based on evaluation of expression of 10 miRNAs.
Interpace Diagnostics' ThyGenX™ Thyroid Oncogene Panel molecular diagnostic test is used to improve surgical decision-making for patients with thyroid nodules when standard cytopathology does not provide a clear diagnosis of thyroid cancer. ThyGenX assists physicians in distinguishing between benign and malignant indeterminate thyroid nodules by utilizing state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid malignancies. The ThyGenX panel design is based on the miRInform® test, whose high predictive value has been validated in a recent prospective clinical study involving over 600 patients. Interpace Diagnostics acquired the miRInform test from Asuragen in 2014, and has now enhanced it by upgrading to a NGS platform which provides greater genomic insights and increased panel content.
Better than the competition:
"RE: our Thyroid products, customers continue to be receptive to our combined ThyGenX/ThyraMir assay and we are viewed positively vs. the other products in the market, including Afirma, ThyroSeq2, and Rosetta. We will also be launching enhancements to our Thyroid offering in the next few weeks." Greg Richard (email 9-21-16)
New Version of AccuCEA™ Called "Insights" Provides Physicians Access to 15,000 Patient Database:
AccuCEA is our highly accurate CEA method designed specifically for pancreatic cyst fluids and is especially convenient when used with PancraGEN. Interpace currently performs over 6,000 AccuCEA tests per year for their customers. CEA is a blood fluid chemistry test that is commonly done as part of an initial screening performed on patients suspected of having pancreatic and other types of cancer.
-The only CEA assay validated for use on small volumes (200uL) of cyst fluid.
-Delivers accurate CEA measurements on pancreatic cyst fluids
-Offers physicians more options – reserve cyst fluid for other diagnostic tests
-Results reported within 1-3 business days
The new AccuCEA Insights
service provides physicians for whom the Company has already provided first line testing, with additional information on how those results compare to those of other patients in the Company's proprietary database of over 15,000 patients, thus reporting incremental and valuable information on the patient's potential molecular profile and overall risk for developing pancreatic cancer. When the report is delivered to the ordering physician, they have an opportunity to speak with one of the Company's expert molecular pathologists and discuss the potential benefits of conducting a full, molecular pathology review using PancraGen®, the Company's fully integrated product that considers all the results from first line testing, imaging, cytology, and molecular testing and stratifies the patient in one of 4 risk categories.
Upcoming Events/Presentations: 86th Annual Meeting of the American Thyroid Association (ATA) in Denver, Colorado
The first of the two posters entitled "Molecular Analysis of Thyroid Malignancy Using Cytology Smears by Combined THYGENX™ and THYRAMIR™ testing: A Prospective Study" highlights the clinical performance of the combined ThyGenX + ThyraMIR tests when carried out on Fine Needle Aspirate (FNA) material smeared on cytology slides.
The second poster entitled "The Majority of Non-Diagnostic (Insufficient) Thyroid Nodule Cytology Samples Can Effectively Undergo Molecular (Combined Mutational and MicroRNA Classifier) Analysis Using a Needle Aspiration Approach" demonstrates that Interpace's scientists were able to perform molecular analysis in cases where cytology results were insufficient.
Set for presentation of posters 50 and 51 on Sept 23:
ACG 2016 Annual Scientific Meeting Oct 14-19 in Las Vegas
"DNA Analysis of Pancreatic Cystic Lesions Has Value in Assessing Risk of Future Malignancy"
Oct 19, presented by:
James J. Farrell, MD, Sara Jackson, PhD, Nicole Toney, MPH,
Tamas Gonda, MD, Yale University School of Medicine, New
Haven, CT, Interpace Diagnostics Corporation, Pittsburgh, PA,
New York-Presbyterian/Columbia University Medical Center, New
"We are attending the ACG mtg. in Oct. in Las Vegas, where data on our PancraGen test is being presented in a podium presentation by Dr. James Farrell of Yale. " Greg Richard (email 9-21-16)