Background, Rationale & Discussion of vivopharm Acquisition
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1 Background, Rationale & Discussion of vivopharm Acquisition Acquired August 2017 August 22, :30am Eastern Dial in :: Webcast :: 1
2 These slides may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 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. 2
3 Overview of Strategic Rationale Several powerful drivers that support the acquisition of vivopharm Significant Customer Synergies Capabilities Beyond Genomics Meaningful Market Expansion Financially Accretive in Year
4 The Fundamentals of vivopharm A solid & highly scalable platform for early discovery, pre-clinical & pharmacology 2 state-of-the-art 200 INDs supported across 20+ indications $5-6 M additional accretive discovery services revenue projected during Year One GLP discovery & early development labs in Pennsylvania & Australia 30+ Immuno-Oncology Studies & Trials ~14% 4 Yr. Revenue CAGR 4
5 Transaction Overview & Fundamentals Details on the acquisition announced by CGIX last week RATIONALE 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. STRUCTURE & VALUE CAPABILITIES FOOTPRINT EXPECTED SYNERGIES BUSINESS IMPACT 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. 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. 5
6 Enhancing Management & Leadership Welcoming Dr. Ralf Brandt, founder of vivopharm 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. PRESIDENT Discovery & Early Development Services 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 6
7 Expanding In The Oncology Value Chain Growing CGI s addressable market and increasing our impact in oncology DISCOVERY PRECLINICAL STUDIES CLINICAL 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 Validation studies Regulatory Filing and Application Preparation Companion Dx Development Indication Expansion Studies LDT Development Monitor Drug Adverse Events Patient Therapy Management Follow-up Monitoring Liquid Biopsy LDT + FDA Testing 7 Cancer Genetics, Inc. NASDAQ: CGIX Q Earnings Call
8 Revenue in $ Billions Well Positioned in a High-Growth Market vivopharm is at an Advantage with Preclinical Demands in Growing CRO Market Total CRO Market Revenue Forecast * Asia-Pacific (including Australia) and Rest of World (ROW) $35.4B $4.9B $30.5B $57.0B $10.2B $46.8B ROW Asia-Pacific (including Australia) 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. 8 *Frost & Sullivan Global CRO Report, 2015: Frost & Sullivan APAC CRO Market Report, 2015 Cancer Genetics, Inc. NASDAQ: CGIX Q Earnings Call
9 Locations and Customers Increase CGI Footprint Highly Scalable labs in US and Australia with Client Services in Germany Hershey, Pennsylvania 15% of Customer Base 16 Employees Munich, Germany 24% of Customer Base 3 Employees % based on count of customer HQs and not on % of revenue Added Locations from vivopharm Acquisition 9 Melbourne, VIC, Australia 61% of Customer Base 14 Employees
10 vp Case Study 1 Ideally positioned to capture downstream revenue from biotechnology clients PROVIDING A SEAMLESS BENCH TO BEDSIDE CAPABILITY THAT SAVES TIME, COST & REDUCES RISK DISCOVERY PRECLINICAL STUDIES CLINICAL TRIALS MARKET ENTRY PATIENT MONITORING Cell line based tumor models to assess antitumor 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 Validation studies Work with IVD and platform partner Establish KOL network with key sites LDT & CDx development Monitor Drug Adverse Events Patient Therapy Management Follow-up Monitoring Liquid Biopsy LDT + FDA Testing 10 Cancer Genetics, Inc. NASDAQ: CGIX Q Earnings Call
11 VP Case Study 2 Cross-selling based on high-quality services and unique translational capability PROVIDING A SEAMLESS BENCH TO BEDSIDE CAPABILITY LEVERAGING OUR UNIQUE INSIGHTS & FOCUS ON ONCOLOGY DISCOVERY PRECLINICAL STUDIES CLINICAL TRIALS PATIENT MONITORING CURRENT STATE. FUTURE STATE Syngeneic IO (immunooncology) 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 11 Cancer Genetics, Inc. NASDAQ: CGIX Q Earnings Call
12 Expanding CGI s Customer Bookings, Diversifying Client Base & Geographic Reach Bookings by Region New v. Existing Clients EU 33% AUS 50% Client Type Existing Clients 56% New Clients 44% Both 11% US 17% Safety & Pharmacology 37% Efficacy 52% 12 C Company Updates 2017 Cancer Genetics, Inc. 12
13 Historical Financials of vivopharm All figures are based on AUS $ and AUS GAAP and fiscal year ending on June 30 FY Revenue in (AUS $) Thousands FY Profits in (AUS $) Thousands $4263 $4747 $5504 $ $462 $ FY 2013 FY 2014 FY 2015 FY C Company Updates 2017 Cancer Genetics, Inc $148 $-38 FY 2013 FY 2014 FY 2015 FY 2016 All figures are Australian GAAP and not reconciled to US GAAP All figure are historical and may not represent future results All figures are based on fiscal years ending on June 30 FY 2015 net loss represents an inclusion of a one time payment
14 Why Australia? COST EFFECIENT Attractive R&D tax incentives. 28% cheaper than U.S before tax incentives. 60% cheaper than US after tax incentives. SPEED Flexible clinical trial process without compromising quality. QUALITY Expansive network of universities, medical research institutes, clinical trial. networks, biobanks and CRO s. Scientists research ranks highest in Asia-Pacific in terms of productivity and impact. Strongest patent protection systems in the world. High-quality infrastructure ENABLES for a large number of clinical researchers with expertise. UNIQUE Growing multicultural population. 43% of the national population was either born overseas or have a parent who was. Planned immigration programs have brought around 6 million people from over 150 countries since GLOBALLY RECOGNIZED Recognized as being a hub for early phase clinical trials. More than 1000 research projects per year. 14 Cancer Genetics, Inc. NASDAQ: CGIX Q Earnings Call
15 Australia Biopharma Services are a Growing & Attractive Market NUMBER OF CLINICAL TRIALS STARTED IN A YEAR IN AUSTRALIA 1,304 16% 1, TOTAL CRO MARKET: REVENUE FORECAST, AUSTRALIA, Phase 1 Phase 2 All other phases Source: Frost & Sullivan. Australia CRO market report: Early Phase Clinical Trials are Set to Drive the Australian CRO Market Revenue ($ Million) Source: ANZCTR. Australian New Zealand Clinical Trial Registry Website. Published Accessed May 1, Cancer Genetics, Inc. NASDAQ: CGIX Q Earnings Call
16 Australia has Proven to Be More Cost Effective Cost of Early Stage Clinical Trial Shows Less than U.S Cost Comparison for a Standardized Early-Stage Clinical Trial Study Conducted in Australia and the United States % 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. 0 USA Index Australia Index (pre Tax Incentive) Australia Index (post Tax Incentive) Pricing data converted to Index, with the US study cost indexed to 100. USA Index Australia Index (pre Tax Incentive) Australia Index (post Tax Incentive) Cost comparison for Phase 1 clinical trials in the US and Australia. Novotech cost comparison case study
17 Key Research & Development (R&D) Tax Incentives Aggregated Annual Company Turnover Company Tax Position Realized Value per R&D Dollar < AUD 20 Million < AUD 20 Million > AUD 20 Million 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** 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. 17 Clinical Trials Capability Report. Australian Trade Commision Australian Clinical Trials Website:
18 High Quality Researchers 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. 18 SCIMagoJournal and Country Rank, Website:
19 Strong Patent Protection Intellectual Property Rights Index (Overall), The International Property Rights Index Website:
20 Flexibility In The Clinical Trial Process Is Conducive For Early Stage Discovery And Development 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. DRUG DISCOVERY PRECLINICAL CLINICAL TRIALS FDA DRUG DISCOVERY PRECLINICAL CLINICAL TRIALS 20 Clinical Trials Capability Report. Australian Trade Commision Australian Clinical Trials Website:
21 IO drugs continue rapid rise. Finding and monitoring patients becomes central to maintain effectiveness $2.21 Bn $1.83 Bn ~ $22 Bn $123 MN 21 1Q Q Q 2017 Immuno-Oncology Rx Sales 2021(e)
22 Deal Rationale & Summary 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. Acquired August 2017 USD $12 Million 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. 22
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