background, rationale & discussion of vivopharm …...cost comparison for phase 1 clinical...

22
1 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

Upload: others

Post on 29-May-2020

2 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

1

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

Page 2: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

2

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

Page 3: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

3

Overview of Strategic RationaleSeveral powerful drivers that support the acquisition of vivoPharm

02

03

04

01

Significant Customer Synergies

Capabilities Beyond Genomics

Meaningful Market Expansion

Financially Accretive in Year 1

Page 4: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

4

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

Page 5: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

5

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

Page 6: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

6

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

Page 7: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

7

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

Page 8: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

8

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

Page 9: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

9

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

Page 10: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

10

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

Page 11: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

11

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

Page 12: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

12

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

Page 13: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

13

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

Page 14: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

14

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.

Page 15: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

15

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

Page 16: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

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

Page 17: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

17

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.

Page 18: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

18

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

Page 19: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

19

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.

Page 20: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

20

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

Page 21: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

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

Page 22: Background, Rationale & Discussion of vivoPharm …...Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study. 2016 Australia has Proven

22

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