GenMark Diagnostics TRANSFORMING MULTIPLEX MOLECULAR TESTING. January 2016

Transcription

1 GenMark Diagnostics TRANSFORMING MULTIPLEX MOLECULAR TESTING January 2016

2 Forward-Looking Statements This presentation contains forward-looking statements about GenMark Diagnostics, Inc. These statements involve known and unknown risks that relate to the Company s future events or future financial performance and the actual results could differ materially from those discussed in this presentation. Factors that may cause the Company's actual results to differ materially from those discussed in the presentation, include: failure to develop the Company s eplex system with the capabilities the Company intends to offer; failure of the Company s products to gain market acceptance domestically or internationally; the refusal of third-party payors to reimburse the Company s customers for use of diagnostic systems and tests; the loss of the Company s largest customer; the Company s history of net losses; increases in the Company s projected expenditures on sales and marketing, research and development and administrative activities; less than anticipated growth in the market for diagnostic testing generally and for the tests the Company is developing or may develop in the future; inability to obtain regulatory clearance or approval for any of the Company s products; changes in the regulatory environment which may adversely impact the commercialization of the Company s new products and result in significant additional capital expenditures; failure to enter into or maintain successful strategic alliances, which may delay the development or commercialization of the Company s products or may result in significant additional expenditures; failure to obtain sufficient funding for the continued development and commercialization of the Company s products; inability to attract or retain skilled personnel for the Company s product development and commercialization efforts; and inability to protect the Company s intellectual property and operate the Company s business without infringing upon the intellectual rights of others, which could result in litigation and significant expenditures. Additional risks and uncertainties relating to the Company and its business can be found in the "Risk Factors" section of GenMark's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings with the United States Securities and Exchange Commission. The forward-looking statements contained in this presentation represent the Company s estimates and assumptions only as of the date of this presentation and the Company undertakes no duty or obligation to update or revise publicly any forward-looking statements contained in this presentation as a result of new information, future events or changes in the Company s expectations. 2

3 Fourth Quarter 2015 Positive Preliminary Results Q4 revenue grew 35% over prior year From $9.8 million to $13.2 million Annual revenue exceeded $39.4 million 29% growth over 2014 Q4 Installed Base grew by 17 analyzers 633 XT-8 analyzers in end user labs Preliminary results subject to change. 3

4 eplex Progress Recent Accomplishments Initial internal and external alpha studies completed Manufacturing transfer completed Analytical studies initiated European launch on track for Q1 Preliminary results subject to change. 4

5 GenMark s Solution Today Random/Continuous Access, Scalable Amplified patient sample Add proprietary label Load mixture Insert cartridge Patient results 5

6 GenMark s Core Technology Electronic DNA detection Speed, specificity, & sensitivity True multiplexing Simplicity & cost advantage Approx. 150 patents/applications 6

7 GenMark Business Overview Strong Growth Business, Innovative eplex System & Assay Pipeline Attractive Razor/Razor Blade Model Drive revenue by growing installed base & increase test menu Growing Installed Base of XT-8 Systems 93 placements in 2015 Continued opportunity in US market eplex System & Test Menu will Drive Rapid Growth Decentralize testing with true random access, sample-to-answer multiplexing Seven assays in development to deliver rapid menu growth % CAGR Actual 2010 Actual 2011 Actual 2012 Actual 2013 Actual 2014 Actual 2015 Actual Existing analyzer installed base Net new analyzer placements Total XT-8 Analyzers Placed

8 GenMark s Solution: Future Sample-to-answer, Random/Continuous Access, Scalable Extraction PCR Detection 4-6 HOURS MINUTES Load Sample Load Cartridge Report Results Management estimates subject to change. 8

9 eplex System Uniquely Differentiated Customer Value Proposition Testing Efficiency Fully integrated, extraction to result True random & continuous access Modular & scalable SHIFT THROUGHPUT PER TOWER* Clinical Value High sensitivity & specificity Multiplex assays Reduce reflex testing Rapid time to result drives informed treatment decisions *Based on an 8hr shift / 60 min turnaround time 9

10 Target Customers eplex System Dramatically Expands Customer Base Globally US ONLY ~1,000 Post-PCR Labs GLOBAL OPPORTUNITY >12,000 Hospitals Management estimates subject to change. 10

11 eplex Menu Opportunity Initial Focus on Infectious Disease Market Multiplex Tests with 10+ targets GI $800M Sepsis $400M RP $250M CNS $140M $2.3B+ Global Market HCV $100M Fungal $75M Pipeline $500M+ Source: Decisive Bio-Insights 2012, LEK 2009, Management estimates 11

12 Fragmented Competition Increasing Emphasis on Multiplex IVD MDx Low-plex Multiplex Centralized Decentralized Companies listed are representative. Positioning reflects management s current opinion and is subject to change. 12

13 eplex Innovation Core Technologies Drive Competitive Differentiation Core esensor Technology Electronic DNA detection Best-in-class specificity & sensitivity Electrowetting Technology Versatile fluid management using digital microfluidics Precision dispensing and mixing Enables rapid time to result Innovative Cartridge Design On-board reagents Universal programmable cartridge Efficient, sample-to-answer performance 13

14 eplex Alpha Studies Easy to Use, Fast and High Concordance Internal Alpha Study High throughput: 120 samples per shift Excellent detection of co-positives High concordance with BioFire RP External Alpha Study Fast: ~90 minute turnaround time Easy to load cartridge, scan, and run Intuitive workflow and user-friendly software High concordance with best-in-class XT-8 RVP test 14

15 Competitive Product Features eplex Core Technology Drives Competitive Differentiation ATTRIBUTE GENMARK BRUKER MALDI LUMINEX CEPHEID BIOFIRE Multiplex Sample-toanswer --- Random & Continuous Access Multi-sample capacity --- Management estimates subject to change. 15

16 eplex Development Milestones European Launch & FDA Submission Timeline Manufacturing Transfer European IVD Launch FDA Submission Q Q Q Analytical & Clinical Studies Management estimates subject to change. 16

17 Management & Board PROVEN MANAGEMENT TEAM Hany Massarany President & Chief Executive Officer Ventana, Roche Diagnostics, Bayer Diagnostics, Chiron Diagnostics Scott Mendel Chief Financial Officer The Active Network, GE Healthcare Jon Faiz Kayyem, Ph.D. Founder & SVP, R&D Efficacy Capital, Motorola Life Sciences, Clinical Micro Sensors Ingo Chakravarty SVP, International Gen-Probe, Roche Diagnostics, Ventana Michael Gleeson SVP, North American Commercial Operations SYBASE, GuardianEdge, BEA Systems Eric Stier SVP, General Counsel & Secretary Hologic, Gen-Probe, Latham & Watkins LLP Jennifer Williams SVP, Human Resources Cerberus Operations & Advisory Co., HD Supply, The Home Depot EXPERIENCED BOARD James Fox, Ph.D. Chairman Daryl J. Faulkner Director Lisa Giles Director Michael Kagnoff Director Kevin C. O'Boyle Director Hany Massarany President & Chief Executive Officer 17

18 Key Investment Highlights Differentiated technology enables access to a large, growing market XT-8 system addresses customer needs and delivers superior performance eplex system addresses future customer needs with a truly differentiated solution in a significantly expanded market Business model delivers value to both customers and shareholders Management team with broad and deep industry experience 18