Upload
redchip-companies-inc
View
3.328
Download
3
Tags:
Embed Size (px)
DESCRIPTION
Cgix investor presentation Oct 2014
Citation preview
Empowering Personalized Cancer Treatment
October 2014
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 2
Forward-Looking Statement
This presentation contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development and potential opportunities for Cancer
Genetics, Inc. products and services or Gentris, Inc. products and services, along with other
statements about the future expectations, beliefs, goals, plans, or prospects expressed by
management constitute forward-looking statements. Any statements that are not historical fact
(including, but not limited to, statements that contain words such as "will," "believes," "plans,"
"anticipates," "expects," "estimates") should also be considered to be forward-looking statements.
Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent
in the development and/or commercialization of potential products, risks of cancellation of customer
contracts or discontinuance of trials, risks related to integration of the acquisitions of Gentris and
BioServe and the realization of the currently anticipated benefits, uncertainty in the results of clinical
trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual
property rights and other risks discussed in the Company's Form 10-K for the year ended December
31, 2013 and 10-Q for the quarter ended June 30, 2014 along with other filings with the Securities
and Exchange Commission. These forward-looking statements speak only as of the date hereof.
Cancer Genetics disclaims any obligation to update these forward-looking statements.
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 3
Focused On Personalizing Cancer Diagnosis and Treatment Globally Through Genomics
Develop & Commercialize Unique Targeted Panels For The
Comprehensive Assessment of Cancer
Develop Compelling Collaborations With Leading Institutions To Support
Genomic Test Adoption, Validation & Health Economics
Establish Sales, Marketing & Commercial Infrastructure In US & India
Serve Both the Clinical and Biopharma Communities Leveraging A
Standardized Global Infrastructure
Selectively Acquire Companies & Capabilities That Further Our Mission of
Impacting The Personalization of Cancer Diagnosis & Management
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 4
Molecular Diagnostics are Changing our Understanding of Cancer While Providing New Tools to Diagnose & Treat Patients
Our unique focus & approach supports the entire cancer care continuum
Personalize
therapeutic plan and
treatment options
DIAGNOSIS PROGNOSIS THERANOSIS
Assist in patient
outcome and disease
management
What drug(s) to give, how
much, and when?
What are my survival
prospects?
Do I have cancer and
what type?
Use genomics to provide
an accurate and definitive
typing of the cancer
Proprietary Products Focused Oncology Lab Comprehensive Report
Integrated Molecular Diagnostic Testing Brings Benefits
Across the Entire Oncology Ecosystem
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 5
CGI’s Mission is to Personalize and Improve the Success Rate in Cancer Treatment
Integrating & Delivering Genomic Information About a Patient’s Cancer
Can Improve Care & Reduce Cost
Phenotypic &
Physical Examination
Morphologic &
Pathological Analysis
Large & Multiple
Specimens Required
Significant Delays to
Treatment
Traditional Approach
Biomarkers and
Companion Diagnostics
Genomic Analysis &
Proprietary Algorithms
Reduced Size and
Number of Specimens
Improved Diagnoses &
Treatment Plans
Our Approach: Personalized Medicine
Target For Tomorrow
25%
Situation Today Source: Clinical Trends in Molecular Medicine, Vol. 7, Issue 5
100%
Success Rate Target Success Rate
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 6
The Acquisitions of BioServe India and Gentris Corporation Provide Significant Market Upside & Improve CGI’s Competitive Position
• Growth potential in integrating our oncology-
focused testing capabilities with Gentris’
high-value contracts.
• Expansion of Gentris’ capabilities and
portfolio to include oncology-focused
pharmacogenomics services.
• 24,000 sq. foot lab space (CLIA/CAP/GLP)
with NGS, genotyping, and gene expression
test capabilities.
Gentris Corporation [Closed 7/16/14]
• Access to high-growth Indian diagnostics
market – projected to grow at 15-20% per
annum for the next decade.
• Accelerates next-generation sequencing
development and validation of targeted hot
spot oncology panels.
• Cost-effective expansion of genomic
analysis & informatics capabilities with state
of-the-art 14,000 sq. foot lab.
BioServe India [Closed 8/18/14]
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 7
Our Expansion is Crucial for our Global Positioning as an Industry Leader in Genomics Testing and Services
Clinical Services and R&D 82 Employees as of July 1st
CGI is positioned as leader in oncology-focused genomics and is enabled to deliver
complete solutions to the clinical and research communities.
Clinical & Research Services Addition of 33 employees
Pharmacogenomics Services Addition of 41 employees
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 8
Unique, Scalable and Multifaceted Business Model With A Focus On Providing A Complete Solution
Suite of Products and Services Provides Multiple Growth Drivers and Value to Multiple Parties:
Clinical Community, Biopharma & Medtech
CLINICAL SERVICES
Differentiated and complete
disease-focused solutions
Superior turnaround times
World-class expertise in
genomics and cytogenetics
Serving community hospitals and
labs through unique Expand Dx™
program
BIOPHARMA PARTNERSHIPS
Biomarker and companion
diagnostic development
World-class genomics and
bioinformatics
Drug-specific and cancer-specific
assays
Comprehensive focus in
hematologic & urogenital cancers
PROPRIETARY PRODUCTS
Proprietary molecular
diagnostics & FISH probes
Clinically validated
IP-protected
Sold globally
Probe manufacturing leverages
low-cost, high scale facility in
India
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 9
Our Target Markets in Oncology Testing Comprise Over 615,000 New Lives Annually in the U.S.
Ability to Impact Over 615,000 New Lives Annually in the U.S.
Source: American Cancer Society
156,420 2014 Estimated New Cases
(U.S.)
Death Rate 35%
Hematological: Lymphoma, Leukemia, M. Myeloma
371,610 2014 Estimated New Cases
(U.S.)
Death Rate 16%
Urogenital: Kidney, Bladder & Prostate
86,970 2014 Estimated New Cases
(U.S.)
Death Rate 31%
Gynecological: Cervical, Endometrial & Ovarian
6 Products Launched in Target Segments
Over $6Bn in Annual U.S. Spend on Lab Testing In These Categories
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 10
6 Proprietary Diagnostic Products Commercially Launched & In Market
Incidence Indication
Hematologic Cancers
106,770 (Annual New Cases, Global)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
142,360 (Annual New Cases, Global)
Diffuse Large B-Cell Lymphoma
62,300 (Annual New Cases, Global)
Follicular Lymphoma
17,795 (Annual New Cases, Global)
Mantle Cell Lymphoma
Urogenital Cancers
274,000 (Annual New Cases, Global)
Kidney Cancer
HPV-Associated Cancers (FHACT®)
1,750,000 (Annual New Cases, US)
HPV+ Low Grade Cervical Lesions
Over 2.3 Mn Combined Annual New Cases Globally
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 11
Product Pipeline
Research &
Discovery
Clinical
Development
Commercial
Development
Launch &
Market Entry
Indication
Development Stage
Hematologic Cancers
Multiple Myeloma
Comprehensive Myeloid Panel [NGS-based]
Comprehensive CLL Panel [NGS-based]
UroGenital Cancers
Bladder Cancer
Comprehensive Renal Panel [NGS-based]
Cervical Cancer
HPV-Associated Cancers (FHACT®)
Head & Neck Cancer
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 12
Despite Improved Cancer Care, Case Numbers for Hematologic Cancers are Still Rising
Genomics-Based Tests like MatBA® are Critical and Improve
the Management and Cost of Hematologic Cancers
Source: Genzyme & Nature Source: National Cancer Institute, National Center for Health Statistics, SEER
Dataset of Incidence & Mortality, FDA
1 2 5 12
89
100 80 60 30 2
Number of Years Ago
11.1 12.6
15.5
18.5 20.0 19.7
20.5 21.2
5.6 6.2 7.1
7.9 8.7 8.2
6.9 7.3
1975 1980 1985 1990 1995 2000 2005 2010
Incidence Rate Survival Rate
Identified Leukemia & Lymphoma Subtypes Incidence & Survival Rates for NHLs (US Only, per 100,000)
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 13
MatBA®-CLL/SLL Improves Risk Stratification & Outcome Prediction
Validated in Collaboration w/ Dr. Kanti Rai & Dr. Nicholas Chiorazzi (NSLIJ); 2 Datasets, 322 specimens
Additional Validations being conducted w/ HUMC & Dana Farber; 2 Cohorts, 350+ specimens
█ Favorable
█ Intermediate
█ Unfavorable
█ Favorable/
Intermediate
(no distinction)
38% of cases in our study have
a favorable prognosis falling
under "watch & wait" approach.
8% of cases with unfavorable
prognosis missed by FISH and
caught using MatBA®-CLL/SLL.
Impact on therapy selection &
clinical management of CLL
patients.
Genomic Aberrations Reported
by FISH:
4
Genomic Aberrations Reported
by MatBA®-CLL/SLL:
20
85%
15%
FISH
23%
39%
38%
(Current Method) (CGI Method)
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 14
MatBA® can Group Patients into Risk Groups & Prognostication Classes
MatBA®- CLL / SLL is a diagnostic tool and
prognostic indicator for patient stratification
and improved patient management
Being actively used in clinical care, in clinical trials and in
validation programs with Dana Farber, MSKCC and
HUMC
20 key genetic events/sites classify CLL patients as
having the potential for
Poor outcome = High risk
Intermediate outcome = Intermediate risk
Good outcome = Low risk
Detection of specific genomic imbalance in
CLL/SLL by MatBA®-CLL/SLL correlates
patient risk with time to first treatment
(TTFT) and shorter overall survival (OS)
Patients classified as high risk showed a shorter TTFT
compared to those classified as low or intermediate risk
Patients classified as high risk had significantly shorter OS
times than those classified as low or intermediate risk
Provides additional risk stratification between low and
intermediate risk patients, not currently available in other
tests
Time to First Treatment (TTFT)
Time (months)
Time (months)
Pro
po
rtio
n
Su
rviv
ing
Pro
po
rtio
n T
reatm
en
t-
Fre
e
– GOOD (n=74)
– INTERMED (n=107)
– POOR (n=47)
– GOOD (n=74)
– INTERMED (n=107)
– POOR (n=47)
P = 0.090
P = 0.001
P < 0.001
P = 0.010
Overall Survival (OS)
Leukemia & Lymphoma – Houldsworth, et. al Sept. 18, 2013
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 15
UroGenRA®-Kidney Can Guide Management of Patients with Renal Masses and Appropriate Treatment Selection
Clinical Benefits Include Reduction in Number of Highly Invasive Procedures and Time to
Treatment Initiation, and Better Informed Treatment Selection
Development of diagnostic algorithm
>600 RCC malignant subtypes (in-silico: SNP)
>100 malignant and benign renal neoplasms (in-house: aCGH & FISH)
Retrospective in-house FFPE validation (n>190) CCF
100% diagnostic yield
97% diagnostic sensitivity to distinguish benign from malignant renal neoplasms
93% sensitivity to distinguish malignant RCC subtypes
C. Magi-Galluzzi and E. Klein (Cleveland Clinic)
Prospective ongoing percutaneous core needle biopsy (n>50) MSKCC
Demonstrated ability to diagnose pathologically “unclassifiable” biopsies prior to surgical
intervention
J. Coleman and J. Durack (MSKCC)
PROBLEM
Men and women with renal masses often
undergo unnecessary nephrectomy for
accurate diagnosis and experience delay in
treatment
SOLUTION
UroGenRA® will detect genomic aberrations in a single assay
permitting accurate diagnosis (benign vs malignant, and
malignant subtype) guiding appropriate management and
treatment strategies
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 16
FHACT® - A New Genomic Aid In The Screening & Management Of Cervical Cancer
FHACT® Provides Critical Information Which Reduces
Unnecessary and Costly Colposcopies
Cervical cancer effects nearly 500,000 women globally each year with
nearly 80% in developing countries.
Today, all these women are
referred for colposcopy.
Women with abnormal or unclear Pap smears
55 Million Pap smears per year
3.5 Million Pap smears come back
as unclear/abnormal
2 Million biopsies performed
12,000 cases of cervical cancer
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 17
FHACT® Provides Information for Developing Treatment Plans Potentially Reducing Healthcare Costs & Procedures
FHACT® is the Only 4 Color FISH Probe that can be Used for Cervical Cancer Screening
as Additional Testing Before Referral for Colposcopy
Global Validation Partners Genomic Amplification by Disease Category
Source: P. Luhn, J. Houldsworth, et al., Gynecologic Oncology (2013)
5 10 19 20
0
20
40
60
80 ptrend = 0.01
6 9 9 20
0
20
40
60
80 ptrend = 0.02
6 9 7 12 0
20
40
60
80 ptrend = 0.03
3 8 12 12 0
20
40
60 ptrend = 0.001
<CIN2
& NLIM
(n=11)
<CIN2
& LSIL
(n=20)
CIN2
&/or HSIL
(n=10)
CIN3+
(n=7)
<CIN2
& NLIM
(n=11)
<CIN2
& LSIL
(n=20)
CIN2
&/or HSIL
(n=10)
CIN3+
(n=7)
FHACT® detects irreversible changes in
cervical cells caused by HPV.
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 18
IP Position and Detailed Global Strategy
Strong and growing portfolio in molecular-focused patents for disease
identification and stratification
IP-based on unique algorithms across a broad group of chromosomal regions
Validation of specific clinical endpoints that are associated with
particular disease outcomes or decisions
Filing and maintenance of trademark portfolio
Tool for Diagnosis and Prognosis of Mature B-Cell Neoplasms US Issued Patent 8,580,713 US Issued Patent 8,557,747 Europe 10803548.6 India 6657/DELNP/2012 Canada 2,785,656
Methods of Analyzing Chromosomal Translocations Using Fluorescence In Situ Hybridization (FISH)
US Issued Patent 7,585,964 US Issued Patent 7,964,345 Canada 2,447,320
Panel for the Detection and Differentiation of Renal Cortical Neoplasms
US Issued Patent 8,603,948 US 14/078,726 Europe 08844570.5
Methods for Detecting Human Papilloma Virus-Associated Cancers
US 13/227,027 US 13/474,111 PCT/US2011/050681
Methods and Tools for the Diagnosis of Female Gynecological Cancers and Precancers
US 61/581,350
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 19
Large, Targeted Market Opportunities
Target Markets Commercialization Strategy
Community Hospitals
Regional Cancer Centers
Oncologists and Pathologists
Continue to growing sales force that calls on hospitals
and regional laboratories
Plan development of national footprint through Expand
Dx™
Biotechnology Companies
Pharmaceutical Companies
Leverage clinical infrastructure and proprietary product
portfolio for testing services that support clinical trials
Expand sales emphasis of Select One®
Emerging Markets
Enhance distributor base in select emerging economies
Partner with leading local cancer care providers and
hospitals to provide probes, arrays and clinical services
Collaborate to create and validate microarrays and other
proprietary products
Accelerate launch of large scale studies
Universities and Research Centers
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 20
Unique Service Offering Developed to Enable Community Hospitals to Improve Cancer Outcomes & Treat Patients Locally
Delivers better outcomes to
community hospitals and laboratories
Enables community hospitals to bring
“state-of-the-art” genomic testing to
patients
Brings personalized medicine to the
community hospital vs. just at
academic and teaching hospitals
Allows community hospitals to keep
patients and treat them locally
Improving care and quality is critical to
maintaining reimbursement for
community hospitals
$600,000 - $800,000 USD in Testing
Opportunity on Average per Hospital
Expanding & Developing Cancer Care is a
Top Priority for Hospital CEOs & CFOs
4,000 to 5,000 Community Hospitals
& Laboratories in the U.S.
85% Of All U.S. Cancer Patients are Initially
Diagnosed in Community Hospitals &
Laboratories
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 21
Through Acquisition, Clinical Trial Services Show Strong Growth and Robust Pipeline
Gentris Provides Pharmacogenomic Clinical Trial Services to Several Large Pharma
Companies Including Merck, Novartis, Otsuka, Eisai and Bristol-Myers Squibb
GROWTH IN CGI’s SELECT ONE®
CONTRACTS ($000)
21%
55%
ONCOLOGY DRUGS ASSOCIATED WITH
BIOMARKER(S)
$300
$2,700
$8,500
$18,000
2011 2012 2013 2014
Approximate value of contracts with biotech and pharma clients
2011 2016
Source: Company Analysis and Management Estimates
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 22
Over 6,800 Oncology Trials in the US Aligned with our Core Markets
Number of Open Clinical Trials (U.S.)
1,439 1,453
2,178
1,765
Lymphoma Leukemia Urogenital HPV-Associated
Source: www.clinicaltrials.gov
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 23
Gilead is Currently Using a Comprehensive Panel of CGI Services & Proprietary Products in National & International Trials for
Hematologic Cancers
The Gilead Relationship Exemplifies the Significant Upside Potential of
CGI’s Select One® Offering
Highlights
Comprehensive, biomarker-based patient profiling will help risk stratification and response monitoring
Improved patient profiling will result in improved trial efficacy for Gilead
Testing will occur across several methodologies, including flow cytometry, FISH, sequencing and
mutation assays, and MatBA® microarrays
CGI provides biomarker driven insight regarding patient targeting and potential outcomes
Trials cover both national and international locations with all patient specimens being processed in
Rutherford, New Jersey
CGIX Press Release: Cancer Genetics, Inc. Selected By Gilead Sciences, Inc. to Provide Clinical Trial Services for International Trials in Chronic Lymphocytic Leukemia
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 24
Roche Partnership Expanding Market Presence Internationally
“By expanding our relationship, we are strengthening our ability to provide patients the best
service possible.” Alvaro Soto, Roche Servicios, Central America & Caribbean General Manager
Highlights
CGI provides genomic and biomarker testing services to 14 countries
in Central America and the Caribbean.
CGI won a global RFP to help a strategic personalized medicine initiative for Roche Servicios (Latin
America)
Roche sends all patient samples to the Rutherford facility where they are catalogued and processed
CGI interacts with both Roche and the hospital staff (pathologists, oncologists and nurses) and
supports delivery of reports through an online HIPAA compliant portal
CGI and Roche expanded this relationship in 2013 and will begin developing workshops and training
programs to drive adoption of biomarker-based cancer diagnostics throughout Central America and
the Caribbean
CGI and Roche recently further expanded this relationship with an exclusive multi-year deal in which
CGI will develop a center of excellence for lung cancer testing utilizing Roche’s FDA-Approved
cobas® platform
CGIX Press Release: Cancer Genetics, Inc. selected by Roche Servicios S.A. to provide services for the diagnosis and personalization of oncology treatment
CGIX Press Release: Cancer Genetics, Inc. expands relationship with Roche Servicios S.A.
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 25
AstraZeneca Partnership A Testament to the Growing Global Awareness of the Value of the CGI Brand
“We chose to partner with Cancer Genetics in this endeavor because of their experience in
biomarker-based diagnostic testing and their commitment to delivering timely and accurate results
to healthcare professionals and patients.” Rodrigo Fernandez, Country President of AstraZeneca CAMCAR, S.A.
Highlights
CGI will provide biomarker and molecular based testing services focused on select oncology
categories and trials
Services include complex testing for diagnosis and prognosis of cancer patients in Central America
and the Caribbean
CGI will work in close conjunction with AstraZeneca on exploring expansion opportunities into
additional geographic territories, further oncology categories, and into select oncology trials
The partnership will concentrate on multiple cancer categories, with lung cancer being an initial
area of focus
CGIX Press Release: Cancer Genetics, Inc. Announces Partnership with AstraZeneca to Provide Biomarker & Molecular Based Testing
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 26
Collaborations with Premier Cancer Research Institutions Leading Differentiated Research & Driving Product Adoption
Research Collaboration/
Licensing
Clinical
Services
Partnership
Highlights
Kidney Cancer, DLBCL, MCL & FL
Joint Venture Focused on Oncology & Next
Generation Sequencing
Cervical Cancer
DLBCL
CLL
Cervical Cancer & DLBCL
Cervical Cancer
Kidney Cancer
DLBCL, Head & Neck Cancers
CLL
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 27
Mayo Clinic Joint Venture Investing in the Future – OncoSpire Genomics
The Value and Focus of Next Generation Sequencing is Moving from Platforms to Clinically
Relevant, Disease-Specific Applications
Highlights
JV, based in Rochester, MN, will develop clinical diagnostic products and services on NGS platform(s)
in areas of high clinical need
Three initial projects in key oncology categories selected by the SRC (Scientific Review Committee):
Lung Cancer, Multiple Myeloma, Follicular Lymphoma
CGI commits up to $6 M over initial three year period (2013 to 2015-16 expected)
Mayo commits to “in-kind” services and support, use of facilities, NGS capabilities and access to
biorepository
Joint Venture is exclusive in the project areas selected by CGI & Mayo
Important company update and analyst day held November 22, 2013
Next Generation Sequencing in Oncology
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 28
OncoSpire Genomics Projects are Unique and Have High Value
1.6 million
new cases
200,000
new cases
20,920
new cases
Informed
Discovery
Clinical
Development
Commercial
Development
Market Entry
(with partners)
Lung Cancer
Multiple Myeloma
Follicular Lymphoma
Selected Projects Have Significant Clinical Value & May Yield Multiple Focused
Panels to Become the Standard of Care in NGS-Based Oncology Management
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 29
Strong History of Growth CGI Revenue & Clinical Volume Trends (2009 – 2013)
54% Full Year 2013 Revenue Growth
$1.67
$2.52
$3.02
$4.30
$6.61
2009 2010 2011 2012 2013
2,321
3,146 3,622
6,610
10,771
2009 2010 2011 2012 2013
Total Revenue ($Mn) Clinical Volume (Tests Processed)
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 30
Strong History of Growth - Revenue & Clinical Volume Trends (Q2 Comparison 2012-2014)
$1,148
$1,832
$3,231
Q2, 2012 Q2, 2013 Q2, 2014
Total Revenue ($000)
1,623
3,204
2,664
Q2, 2012 Q2, 2013 Q2, 2014
Clinical Volume (Tests Processed)
Combined CGI
& Gentris
Revenue
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 31
Summary Statement of Operations (1st Half Comparison 2012-2014)
Income Statement Item 1H, 2012 1H, 2013 1H, 2014 Combined 1H, 2014*
Revenue $1,983 $3,050 $2,942 $6,508
Gross Profit 74 701 149 1,781
Gross Margin (%) 3.7% 23.0% 5.1% 27.4%
Research & Development (R&D) 1,050 951 1,703 2,043
Sales & Marketing (S&M) 716 832 1,667 1,703
General & Administrative (G&A) 2,329 2,961 5,127 7,092
Operating Profit (Loss) (4,021) (4,043) (8,348) (9,056)
Net Income (Loss) (2,933)
(6,782)
(6,673)
(7,417)
$ in thousands
* The “Combined 1H, 2014” results are the aggregation of first half 2014 of both Cancer Genetics, Inc. and Gentris Corporation. The amounts may not be indicative
of future results.
Actual 06/30/14
All Cash* $43,418
Stockholders’ Equity 40,463
$ in thousands
* All cash included $6,000 restricted to collateralize a credit line
Balance Sheet Information
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 32
Consistent Focus on Gross Profit Improvements Additional Efforts Focused Operationally in US & India
Gross Profit Margin Highlights of Initiatives
(52%) (39%) (3%)
9%
26%
(1,000)
(800)
(600)
(400)
(200)
0
200
400
600
800
2009
2010
2011
2012 2013
$ in T
housands
Decrease CGI Costs for
Development & Services
Migrate DNA manufacture and
NT Kits for CGI probes
Develop remove G-Band analysis
capability
Develop remote FHACT®
analysis capabilities
Move entire probe manufacturing
& assembly
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 33
Multiple Customer Types Provide Diversified Revenue Mix With Covered Lives Already in Place
Selected Payors
Direct Bill Customer Types
Biotechs
Pharmas
Academic
Cancer Facilities
Community &
Regional Labs
72+ million covered lives through multiple payors:
18%
21% 58%
3%
Medicare
3rd Party
Insurance
Companies,
Hospitals
& Care
Facilities
Payor Revenue Mix 1H, 2014
Reimbursement Based Direct Bill / Pay Based
3rd Party Insurance
Medicare
1H, 2014
Probes
Companies, Hospitals
& Care Facilities
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 34
Experienced and Focused Management and Boards
Scientific Advisory Board
Andrea Califano, Ph.D. Chairman of the Columbia Initiative for Systems Biology
Associate Director for Bioinformatics, Herbert Irving Comprehensive Cancer Ctr
Timothy A. Chan, M.D., Ph.D. Principal Investigator, Human Oncology and Pathogenesis Program at
Memorial Sloan-Kettering Cancer Center
Riccardo Dalla-Favera, M.D. Director, Institute for Cancer Genetics at Columbia University
Vundavalli V. Murty, Ph.D. Director, Cancer Cytogenetic Laboratory and Molecular Pathology at Columbia
University
Hans-Guido Wendel, M.D. Principal Investigator, Cancer Genetics Laboratory at Memorial Sloan-Kettering
Cancer Center
Howard McLeod, PharmD Medical Director, DeBartolo Family Personalized Medicine Institute, Moffitt
Cancer Center
Andrew D. Zelenetz, M.D., Ph.D. Chief of Lymphoma Service and Head of Molecular Hemo-Oncology
Laboratory, Department of Medicine at MSKCC
Raju Chaganti, Ph.D., FACMG Founder
• 35+ years in cancer research; 38 at MSKCC
• Major discoveries in cancer genomics
• Published 350+ articles, 4 patents
Panna Sharma President & CEO
• 15+ years as advisor to global life science & healthcare cos.
• Founded TSG Partners
• Chief Strategy Officer, iXL (IIXL)
Edward J. Sitar Chief Financial Officer & Treasurer
• 30+ yrs in finance & deal making in the healthcare industry
• Healthagen, ActiveHealth Management, Cadent Holding, MIM Corporation
(Bioscrip), Vital Signs, Zenith/Goldline Pharmaceutical, Coopers &
Lybrand
Jane Houldsworth, Ph.D. Vice President of R&D
• 25+ years in translational oncology research
• Published 50+ articles, 4 patents
• NIH grantee
Chairman of the Board, | Keith Brownlie, CPA | Edmund Cannon | Raju Chaganti, Ph.D.
John Pappajohn | Franklyn Prendergast, M.D., Ph.D. | Paul Rothman, M.D. | Panna Sharma
Board of Directors
Officers & Management Team
2014 Cancer Genetics, Inc. | NASDAQ: CGIX | 35
Consistent Achievement of Milestones Expected in Coming Quarters
Increasing covered lives market access
through additional payers & health care
organizations
Launching multi-marker NGS panel for
lymphoid malignancies
Additional international agreements with
life science tools companies for DNA
Probes and product distribution in key
geographies
MatBA® – Next phase of data and results
from Dana Farber and HUMC studies to
help support value and reimbursement
Pursuing CE approval for IVDD use of
FHACT® in E.U.
Additional news on biopharma partners &
relationships
Pursuing additional indications for
UroGenRA®-Kidney microarray
Close of BioServe transaction (Q3, 2014)
Migrated DNA-FISH Probe Manufacturing to India reducing cost, increasing capacity and
improving operational flexibility
Launched UroGenRA®-Kidney, a unique microarray for kidney cancer diagnosis in collaboration
with MSKCC
Collaborative Study of UroGenRA®-Kidney with Cleveland Clinic demonstrated 93% diagnostic
accuracy – announced results at the AACR 105th Annual Meeting
Launched FHACT® outside the U.S. in collaboration with the National Cancer Institute research
publication and in the U.S. as an LDT under CLIA
Promoted FHACT® at the ACOG Annual Meeting
Received CLIA Approval for MatBA®-MCL (Mantle Cell Lymphoma)
Finalized Agreement with Multiplan and Three Rivers which gave us access to 72+ million
covered lives
Launched OncoSpire Genomics – A Next Generation Sequencing Joint Venture with Mayo
Clinic and announced initial set of projects (lung cancer, multiple myeloma & follicular lymphoma)
Launched CALR Mutation Test – for the diagnosis of myeloproliferative neoplasms potentially
evolving into acute leukemia
Announced Multi-Year PathAdvantage Collaboration – for FHACT® (cervical cancer)
Partnered with AstraZeneca – CGI will provide biomarker-based Dx in Central America and the
Caribbean
Acquisition of Gentris Corporation – closed on July 16, 2014
Recent
Accomplishments Upcoming Milestones
and Value Drivers
For further information, please contact us at [email protected]
Cancer Genetics, Inc.
Meadows Office Complex
201 Route 17 North
Rutherford, NJ 07070
(201) 528-9200
www.cancergenetics.com
100214