Professional Documents
Culture Documents
October 2016
IDXG
FORWARD-LOOKING STATEMENTS
Our Mission
Brief History
PDI founded by Pat Dugan in 1988 who today still owns approximately 30%
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
Additional pipeline tests include an assay for Barretts esophagus and biliaryboth
launching in Q4 2016
Rapidly growing revenues (60% y-o-y) and test volumes in proprietary, high-value
space
Endocrine
Powered by PathFinderTG
Pancreatic Cysts
Thyroid Nodules
$350M
$350M
Pancreatic Cysts
Cancer Risk
Powered by PathFinderTG
Pancreatic Cancer
The Fourth Leading U.S. Cancer Killer
159,260
50,310
45,000
39,590 40,430
39,590
U.S. deaths
29,480
14,270
4,020
Cervix
Prostate
Breast
Lung
Source: ACS Cancer Facts & Figures 2014; all figures annual
PancraGEN
(formerly PathfinderTG)
Cytology
Imaging
Fluid Analysis
(CEA , Amylase)
Pathologist
Review
CEA above 1000 ng/ul with High EUS
Molecular
Diagnostics
6%
Benign
34%
Statistically Indolent
Statistically Higher Risk
52%
Aggressive
8%
Virtual risk assessment using 13,000+ testing & 492 cyst registry pts
Detailed quantitative
molecular profiling integrated
with first-line clinical findings
leading to risk assessment and
clear, management
recommendations
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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
Source: 1Gastroenterology Research and Practice Volume 2012, Article 147465
2Gastroenterology 2015; 148:819-822
Pancreatic cysts:
2-5%
risk of cancer
increasing with
age1
Pancreatic cysts:
80%
surgeries are
benign
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The
Endocrine
Oncology
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Thyroid Nodules
Common clinical problem
~10-18 m
Estimated
525,000
thyroid FNA per year in
US and growing
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+
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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Indeterminate diagnosis
Indeterminate diagnosis
Indeterminate diagnosis
Surgery
Afirma
Combination testing
38% benign
with 93% NPV
62% suspicious
with 47% PPV
61% benign
with 94% NPV
39% malignant
with 74% PPV
Follow
Surgery
Follow
Surgery
33%
10%
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Barretts Esophagus
Risk of progression to cancer
Powered by PathFinderTG
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~3.3M
$2B
Adults
Potential
~850,000
Endoscopic screens
Annually
Same PathfinderTG platform
BarreGen commercial launch expected in 2016
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BarreGEN may help differentiate patients a low risk of EAC from high
risk of EAC prior to visible HGD/EAC morphology
Eluri et al 2015
Results:
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
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1 Eluri
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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.
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PancraGen*
Thyroid
Others,
6%
Others,
6%
Medicare Medicare
, 3% Advantage,
9%
Client
Billing, 11%
Medicare ,
new U.S. cases
35%
39,590
Commercial,
29%
U.S. deaths
Client
Billing, 30%
Commercial,
52%
Medicare
Advantage,
19%
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Endocrine
List Price
$4,000
List Price
$1,675
$4,000
Averaged Realized
Revenue
$2,600
Averaged Realized
Revenue
$1,100
$2,000
Medicare
$3,100
Medicare
$1,057
$2,200
81479
81445
81479
+148 million
+67 million
Covered Lives
+71 million
Covered Lives
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Number of
Lives
Aetna
22,000,000
Cigna
16,000,000
United
34,000,000
CareFirst BCBS
3,340,000
6,600,000
PancraGen
ThyGenX
ThyraMIR
Medical Policy
Coverage
Contract
Pricing
$3,101 PancraGen
3,000,000
TMAC
500,000
$3,600 PancraGen
$3,658 PancraGen
Pending
Pending
Kaiser
9,000,000
Highmark BCBS
5,930,000
ACPN (Network)
NA
NA
$3,200 PancraGen
NA
$3,798 PancraGen
58,000
$3,800 PancraGen
NA
$3,200 PancraGen
MagnaCare
$3,600 PancraGen
lnterwest Health
$3,400 PancraGen
HealthSmart (Network)
$3,200 PancraGen
$3,798 PancraGen
Emblem Health
3,400,000
Harvard Pilgrim
1,000,000
55,200,000
187,628,000
71,288,000
148,870,000
67,540,000
$3,101 PancraGen
(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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Guideline Recommendations
2014 American Thyroid Association Revised Guidelines
MDx Tests should be considered for suspicion of malignancy or indeterminate.
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.
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IDXG
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New Development
GASTROINTESTIONAL(GI) PRODUCTS
ENDOCRINE PRODUCTS
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
Jim Early Chief Financial Officer. Previously CFO at both ABGenomics Intl and
SanGeva BioPharma as well as an interim CFO and BD services consultant to
the medtech industry.
Week 39
YTD GI MDx Orders (actual vs planned)
2016 GI Orders
4000
3500
3000
Orders
2500
2000
GI Actual
GI Planned
1500
1000
500
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52
Weeks
29
Week 39
YTD Thyroid Orders (actual vs planned)
2016 Thyroid Orders
8000
7000
6000
Orders
5000
4000
Thyroid Actual
Thyroid Planned
3000
2000
1000
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52
Weeks
30
Investment Considerations
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THANK YOU!
IDXG
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