background, rationale & discussion of vivopharm …...cost comparison for phase 1 clinical...
TRANSCRIPT
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Background, Rationale &
Discussion of vivoPharm
Acquisition
August 22, 2017
8:30am Eastern
Dial in :: 1-888-554-1430
Webcast :: http://public.viavid.com/index.php?id=126000
Acquired August 2017
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These slides may contain 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 revenues, margins, research, technology, clinical development and potential opportunities for Cancer Genetics, Inc. tests 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 that anticipated benefits from acquisitions will not be realized, 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 Cancer Genetics, Inc. Form 10-K for the year ended December 31, 2016 and the Form 10-Q for the Quarter ended June 30, 2017 along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics, Inc. disclaims any obligation to update these forward-looking statements.
www.cgix.com
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Overview of Strategic RationaleSeveral powerful drivers that support the acquisition of vivoPharm
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Significant Customer Synergies
Capabilities Beyond Genomics
Meaningful Market Expansion
Financially Accretive in Year 1
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The Fundamentals of vivoPharm
200 INDs supported
across 20+ indications
$5-6 Madditional accretive
discovery services revenue
projected during Year One
30+Immuno-Oncology
Studies & Trials
~14%4 Yr. Revenue CAGR2 state-of-the-art GLP discovery & early
development labs in Pennsylvania & Australia
A solid & highly scalable platform for early discovery, pre-clinical & pharmacology
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Transaction Overview & Fundamentals
Purchase price of USD $12M; 90% in CGIX stock (20 day VWAP) and 10% cash (USD $1.2M), and 20%
indemnity escrow of the stock for 12 months.
RATIONALE
STRUCTURE &
VALUE
CAPABILITIES
FOOTPRINT
EXPECTED
SYNERGIES
BUSINESS IMPACT
vivoPharm has industry recognized capabilities in early phase development and discovery, especially in
immuno-oncology models, tumor micro-environment studies, specialized pharmacology services, and PDx
(patient derived xenograft) model studies that support basic discovery, preclinical and phase 1 clinical trials.
vivoPharm will add 34 employees and approximately 14,000 additional square feet of laboratory and office
space in 3 locations with laboratories located in 2 locations - Hershey, Pennsylvania and Melbourne,
Australia – and a client service and project management office in Munich, Germany.
CGI expects to more readily capture downstream (from vP to CGI) clinical trial testing that emerges from
efficacy models and phase 1 safety testing and also provide integrated discovery and preclinical services
from the IO and PDx capabilities (from CGI to vP) that are seamless.
The acquisition is expected to be accretive on a financial basis and also allow CGI to offer fully integrated
drug discovery and development capabilities that enable drug rescue and drug repurposing for oncology and
IO therapies.
Increases market share with biotech and pharma clients by providing earlier access to clinical trials
and capabilities that extend and expand discovery and early development services, especially in IO.
Details on the acquisition announced by CGIX last week
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Dr. Ralf Brandt has over 25 years of experience as a biochemist
and cell biologist with strong international experience in both
predictive tumor models and commercial oncology development
programs.
PhD at Academia of Sciences of Germany
PostDoc at National Cancer Institute, Bethesda, MD
PostDoc - Genetic modified tumor models - at Schering AG, Germany
Project manager - Tumor biology – Novartis AG, Bale, Switzerland
Predictive tumor models - M.D. Anderson Cancer Center, Houston TX
Department Head – Tumor and cell biology, Bionomics Ltd, Australia
Founder vivoPharm Pty Ltd, Australia
Merger and integration of vivoPharm with RDDT
Management of sites across 3 continents, Europe, Australia and USA
Multiple years of profitable safety, efficacy and discovery work for
biotechnology and pharmaceutical companies
Expansion of vivoPharm’ services and globalization of client base
PRESIDENT
Discovery & Early Development Services
Enhancing Management & LeadershipWelcoming Dr. Ralf Brandt, founder of vivoPharm
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Cancer Genetics, Inc. | NASDAQ: CGIX | Q2 2017 Earnings Call
Expanding In The Oncology Value Chain Growing CGI’s addressable market and increasing our impact in oncology
DISCOVERYPRECLINICAL
STUDIESCLINICAL TRIALS
MARKET ENTRY
PATIENT MONITORING
Target Selection
and Validation
Lead Finding and
Optimization
Pre-IND Package
in vivo Models
Imaging Studies
Tumor – Micro
environment
Pharmacokinetics
Pharmacodynamic
Efficacy
Pharmacological
Profiling
Toxicology
Formulation
IND-Enabling
Studies
Phase 1, 2, 3 Trials
Phase 4, Post-
Marketing Studies
Tolerability,
Efficacy, Dosage
Drug Repurpose
and Rescue
Patient Stratification
Progress Monitoring
Monitor Drug
Adverse Events
Patient Therapy
Management
Follow-up
Monitoring
Liquid Biopsy
LDT + FDA
Testing
Validation studies
Regulatory Filing
and Application
Preparation
Companion Dx
Development
Indication
Expansion Studies
LDT Development
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Cancer Genetics, Inc. | NASDAQ: CGIX | Q2 2017 Earnings Call
$30.5B
$46.8B
$4.9B
$10.2B
0
10
20
30
40
50
60
2015 2020ROW Asia-Pacific (including Australia)
$35.4B
Well Positioned in a High-Growth MarketvivoPharm is at an Advantage with Preclinical Demands in Growing CRO Market
vivoPharm’s capabilities and portfolio are
uniquely positioned to meet the pre-clinical
demands of this growing CRO market.
Target screening, identification and validation.
Rodent and small animal pharmacology, efficacy and
toxicity studies.
Clinical trial design, testing and support.
Pre-designed, tumor-derived, cell lines and cultures
for 90 tumor lines.
“24/7” operations and support available due to global
presence.
Biomarker and Bioanalytical services.
*Frost & Sullivan Global CRO Report, 2015: Frost & Sullivan APAC CRO Market Report, 2015
Re
ve
nu
e in
$ B
illio
ns
Total CRO Market Revenue Forecast 2015-2020*
Asia-Pacific (including Australia) and Rest of World (ROW)
$57.0B
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Locations and Customers Increase CGI FootprintHighly Scalable labs in US and Australia with Client Services in Germany
Added Locations from
vivoPharm Acquisition
Hershey, Pennsylvania
15% of Customer Base
16 Employees
Melbourne, VIC, Australia
61% of Customer Base
14 Employees
Munich, Germany
24% of Customer Base
3 Employees
% based on count of
customer HQs and
not on % of revenue
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Cancer Genetics, Inc. | NASDAQ: CGIX | Q2 2017 Earnings Call
vP Case Study 1 Ideally positioned to capture downstream revenue from biotechnology clients
DISCOVERYPRECLINICAL
STUDIESCLINICAL TRIALS
MARKET ENTRY
PATIENT MONITORING
Cell line based
tumor models to
assess anti-
tumor efficacy of
2 pro-enzymes
Assessing
combinations of
2 pro-enzymes
Synergism and
combinations,
etc.
Assessing drug
combination ratios
Human xenografts
to assess efficacy
Syngeneic models
Metastatic models
Identifying early
biomarkers for
patient strat. &
response
Phase 1 safety and
toxicology work
Bioanalytical work
IND preparation
Phase 2 Clinical
Trial handoff to
CGI
Potential CDx
development
Monitor Drug
Adverse Events
Patient Therapy
Management
Follow-up
Monitoring
Liquid Biopsy
LDT + FDA
Testing
Validation
studies
Work with IVD
and platform
partner
Establish KOL
network with key
sites
LDT & CDx
development
PROVIDING A SEAMLESS BENCH TO BEDSIDE CAPABILITY
…THAT SAVES TIME, COST & REDUCES RISK
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Cancer Genetics, Inc. | NASDAQ: CGIX | Q2 2017 Earnings Call
VP Case Study 2Cross-selling based on high-quality services and unique translational capability
DISCOVERY PRECLINICAL STUDIES CLINICAL TRIALSPATIENT
MONITORING
• Syngeneic IO (immuno-
oncology) models
• Customer selection
driven by quality and
superiority over existing
competition
• Superior service,
timeliness and
collaboration
• Extensive in-house capabilities to
acquire knowledge of biomarkers
and genetic expression profiles to
improve tumor models
• Translational biomarker research,
genetic profiling of tumor models –
developing benchmarks and
concepts to support specific IO
clinical study readout (specific
disease related data)
Phase 2, 3 Trials
• Transition into clinical phase studies with CGI
• Applying preclinical IO data and/or biomarker
expression patterns will improve the clinical
study knowledgebase
• Providing a clear regulatory and patient
stratification and monitoring path to accelerate
towards personalized medicine
PROVIDING A SEAMLESS BENCH TO BEDSIDE CAPABILITY
…LEVERAGING OUR UNIQUE INSIGHTS & FOCUS ON ONCOLOGY…
CURRENT STATE…. …FUTURE STATE
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Company Updates | 2017 | Cancer Genetics, Inc. | 12
AUS50%
US17%
EU33%
Bookings by Region
New Clients44%
Existing Clients
56%
New v. Existing Clients
Efficacy
52%Safety &
Pharmacology
37%
Both
11%
Client Type
Expanding CGI’s Customer Bookings, Diversifying
Client Base & Geographic Reach
C
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Company Updates | 2017 | Cancer Genetics, Inc. | 13
Historical Financials of vivoPharmAll figures are based on AUS $ and AUS GAAP and fiscal year ending on June 30
$4263$4747
$5504$5890
0
1000
2000
3000
4000
5000
6000
7000
FY 2013 FY 2014 FY 2015 FY 2016
FY Revenue in (AUS $) Thousands
$462
$148
$-38
$450
-100
0
100
200
300
400
500
FY 2013 FY 2014 FY 2015 FY 2016
FY Profits in (AUS $) Thousands
All figures are Australian GAAP and not reconciled to US GAAP
All figure are historical and may not represent future results
All figures are based on fiscal years ending on June 30
FY 2015 net loss represents an inclusion of a one time paymentC
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Cancer Genetics, Inc. | NASDAQ: CGIX | Q2 2017 Earnings Call
Why Australia?
COST EFFECIENT Attractive R&D tax incentives.
28% cheaper than U.S before tax incentives.
60% cheaper than US after tax incentives.
SPEED Flexible clinical trial process without compromising quality.
QUALITY Expansive network of universities, medical research institutes, clinical trial.
networks, biobanks and CRO’s.
Scientists’ research ranks highest in Asia-Pacific in terms of productivity and impact.
Strongest patent protection systems in the world.
High-quality infrastructure ENABLES for a large number of clinical researchers with expertise.
UNIQUE Growing multicultural population.
43% of the national population was either born overseas or have a parent who was.
Planned immigration programs have brought around 6 million people from over 150 countries since 1945.
GLOBALLY RECOGNIZED Recognized as being a hub for early phase clinical trials.
More than 1000 research projects per year.
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Cancer Genetics, Inc. | NASDAQ: CGIX | Q2 2017 Earnings Call
Australia Biopharma Services are a Growing & Attractive Market
0
200
400
600
800
1000
1200
1400
1600
2010 2015
NUMBER OF CLINICAL TRIALS STARTED IN A YEAR IN AUSTRALIA
Phase 1 Phase 2 All other phases
1,50716%
391.4
439.4
492
548.9
615.9
0
100
200
300
400
500
600
700
2015 2016 2017 2018 2019
TOTAL CRO MARKET: REVENUE FORECAST, AUSTRALIA, 2015-2019
Revenue ($ Million)Source: ANZCTR. Australian New Zealand Clinical Trial Registry Website. http://www.anzctr.org.au/ Published 2015. Accessed May 1, 2016.Source: Frost & Sullivan. Australia CRO market report: Early Phase Clinical Trials are Set to Drive the Australian CRO Market. 2015.
1,304
16
0
50
100
USA Index Australia Index (preTax Incentive)
Australia Index (postTax Incentive)
USA Index Australia Index (pre Tax Incentive) Australia Index (post Tax Incentive)
Cost Comparison for a Standardized Early-Stage Clinical
Trial Study Conducted in Australia and the United States
28%60%
U.S. CRO’s were asked to estimate the
cost of a standard early-phase clinical trial
(Phase 1) to be conducted in the U.S,
while an Australian CRO was asked to
price the same study using the same
specifications and requirements, but to be
carried out in Australia.
Pricing data converted to Index, with the
US study cost indexed to 100.
Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016
Australia has Proven to Be More Cost EffectiveCost of Early Stage Clinical Trial Shows Less than U.S
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Key Research & Development (R&D) Tax Incentives
Aggregated Annual
Company Turnover
< AUD 20 Million < AUD 20 Million > AUD 20 Million
Company Tax Position
LOSS
45% Cash Refund
PROFIT
45% Tax Offset (any
unused offset carried
forward)
PROFIT OR LOSS
40% Tax Offset (with
any unused offset
carried forward)
Refundable Non-refundable* Non-refundable**
Realized Value per
R&D Dollar
45 cents 15 cents 10 cents
*Refundable tax offset: once a company’s tax liability is reduced to zero, companies may access a cash refund for any unused offset amount.
**Non-refundable tax offset: companies cannot access a cash refund for any unused offset amount once their liability has been reduced to
zero. However, these offsets may be carried foreword into future income years.
Clinical Trials Capability Report. Australian Trade Commision. 2015. Australian Clinical Trials Website:
https://www.australianclinicaltrials.gov.au/industry-and-sponsors/why-conduct-clinical-trial-Australia.
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1135
749
616
486
458
274
244
237
233
216
206
H-INDEX (MEDICINE) OF CERTAIN COUNTRIES, 2014
• Australia ranks #1 in Asia-Pacific in terms of H-index, which attempts to measure both productivity
and impact of the publication of the scientists in the country.
SCIMagoJournal and Country Rank, 2014. Website: www.scimagojr.com
High Quality Researchers
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8.6 8.5 8.4 8.4 8.1 8.1 8 7.97.1 6.9 6.5
5.3 5.3
0
5
10
Intellectual Property Rights Index (Overall), 2015
Strong Patent Protection
The International Property Rights Index 2015. Website: http://internationalpropertyrightsindex.org/countries.
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The Australian clinical trial process allows flexibility without compromising on quality:
Companies conducting clinical trials in Australia do not require US FDA Investigation New
Drug application approval.
However, the data output form studies conducted in Australia can be used to support
international regulatory applications, including FDA IND submission.
Clinical Trials Capability Report. Australian Trade Commision. 2015. Australian Clinical Trials Website:
https://www.australianclinicaltrials.gov.au/industry-and-sponsors/why-conduct-clinical-trial-Australia.
DRUG
DISCOVERYPRECLINICAL CLINICAL TRIALS
FDA
DRUG
DISCOVERYPRECLINICAL CLINICAL TRIALS
Flexibility In The Clinical Trial Process Is Conducive For Early Stage Discovery And Development
21 Immuno-Oncology Rx Sales
1Q 20171Q 2015 2Q 2017
$123 MN
$1.83 Bn
$2.21 Bn
2021(e)
~ $22 Bn
IO drugs continue rapid rise….Finding and monitoring patients becomes central to maintain effectiveness
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The acquisition strengthens CGI’s “Bench-to-Bedside” capabilities and
bolsters growth with a global customer base of biopharma partners.
The acquisition expands CGI’s discovery and early development
revenue base with highly complementary biotechnology and
pharmaceutical customers.
The acquisition is expected to be immediately accretive based on
vivoPharm’s history of profitable, above-market growth.
The addition of vivoPharm increases CGI’s immuno-oncology and
pharmacology capabilities by adding more than 55 new projects,
over 30 of which are immuno-oncology focused.
The transaction transforms CGI’s operations and value proposition by
increasing drug identification, drug rescue and drug repurposing
capabilities.
Deal Rationale & Summary
Acquired August 2017
USD $12 Million