delivering diagnostics that improve patient care
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Forward-Looking Statement
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 of the Company’s products to gain market acceptance domestically or internationally;
• failure to scale our manufacturing operations to sufficiently support our anticipated future growth;
• 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.
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 2
Recent Highlights
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 3
✓ 2020 revenue guidance increased from $155 - $165M to $165M - $168M
✓ Commercial launch of ePlex Respiratory Pathogen Panel 2 (RP2)
✓ Received Emergency Use Authorization (EUA) for ePlex Respiratory Pathogen Panel 2 (RP2)
70net new systems
115+ new customers YTD
$6.3Mcash from operations
$193Kaverage annual
annuity/placement
Q3 Highlights:
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 4
Improving Patient Care with Multiplex Molecular Diagnostics
Simple, rapid
and actionableDifferentiated
ePlex® platform
Comprehensive
Pathogen Coverage
Delivering growth +
margin expansion
$
Multiplex molecular
diagnostics to help
improve management
of high-risk patients
Highly scalable
“sample-to-answer”
solution with simplest
workflow
Proven ability to drive
revenue, improve
gross margins,
generate cash
Unique blood culture
ID solution and
sustained leadership
in respiratory testing
5
ePlex: The True Sample-to-Answer Solution® (< 2h)
Load Sample Insert Cartridge Report Results
Conventional Molecular Testing (~6-24h+)
Extraction Formulation Amplification Detection Report ResultsSample Preparation
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved.
Proprietary Technologies Enable ePlex Sample-to-Answer SolutionMakes complex multiplex molecular diagnostics accessible in new care settings
Management estimates subject to change
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 6
$600M+
$140M
$500M+
$450M+
$900M+
Blood Culture ID
Meningitis / Encephalitis
Hepatitis C Genotyping
Other:
MDRO, PJI, SSTI
$100M
Respiratory:
RP and Pneumonia
Gastrointestinal
202020192018 2021 2022
~$1B
Significant Global Market Opportunity for Multiplex Testing$2.5B+ infectious disease market less than 40% penetrated
Market PenetrationTotal Addressable Market
Designed for the Patient,
Optimized for the Lab®
The ePlex System is designed to
improve patient outcomes and
reduce hospital costs
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 7
GenMark is Uniquely Positioned to Win
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 8
IT Integration
• Advanced LIS and integration capabilities provide significant
productivity gains
• Integrated software to link diagnostic results to actionable therapy
Order-to-Report
Efficiency
• Minimal hands-on-time and scalable throughput for managing peak
testing demand
• Simplest workflow enables high-throughput & reduces labor costs
Patient Centered
Care
• Comprehensive pathogen coverage ensures clinically relevant results
• Positive patient ID capabilities designed to reduce avoidable medical
errors and ensure patient safety
Scalable Design Extends ePlex Benefits Across All Segments
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 9
Small Rural
Hospitals
Community
Hospitals
Commercial
Reference LabsLarge Academic Centers
and Hospital Systems
Sam
ple
s p
er
8 H
our
Shift
96
72
48
24
12
2017
51 82
147196
Q1 Q2 Q3 Q4
2018
228267
312354
Q1 Q2 Q3 Q4
2019
393438
489527
Q1 Q2 Q3 Q4
Q3’20 analyzer annuity of $193,000
Growing Installed Base and Increasing Annuity Drives Growth
Cum
ula
tive e
Ple
x A
naly
zers
10 © Copyright 2020 GenMark Diagnostics, Inc. All rights reserved.
2020
581
Q1 Q2Q3 Q4Q2
652
Q3
722
Global Opportunities
11
Targeting additional markets in Middle East, Asia Pacific and Latin America
‒ Direct Sales
‒ Distributors
‒ New market expansion
GenMark Commercial Presence:
• 20 United States Territories
• 10 Field Technical Specialists
• 5 Member Strategic Account Team
• 3 Infectious Disease Specialists
• 25 Distributor Partners in Europe and
certain other geographic regions
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved.
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 12
Addressing the Need for Rapid DiagnosticsRespiratory Infections
More doctor visits and absences from school and work than any other illness1
~500 millionNon-influenza infections annually in the U.S.1,2,3
Traditional Diagnostic Methods
Can delay results by 8-72 hours and
miss >80% of viruses and bacteria that can cause influenza-like illness4
Rapid diagnostic tests can reduce mortality in high-risk groups
The ePlex Respiratory Pathogen PanelsDriving consistent year-over-year growth
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 13
RP Panel detects >20 common respiratory pathogens5
• Achieved CE Mark in Q2 2016 and FDA Clearance in Q2 2017
RP2 & SARS-CoV-2 test launched under FDA EUA
• Rapid response to COVID 19 global pandemic with streamlined workflow
Validated clinical performance (RP Panel)
• U.S. clinical study showed 95.2% agreement with comparator method in
3,235 samples6
Rapid, accurate, actionable results inform patient care
• Established standard-of-care for high-risk patients makes RP the largest
multiplex market segment in the world
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 14
Addressing the Need for Rapid DiagnosticsBloodstream Infections and Sepsis
~30,000,000 affected globally every year7
Most expensive condition in hospitals:
~$18,000 per case8 causing a
death every 4 seconds9
Sepsis mortality increases up to
8%every hour effective
antibiotics are delayed10
10 million
peopleestimated to die
annually due to
antimicrobial resistant
infections by 205011
15Detection rate is based on panel inclusivity only and is not a sensitivity/performance claim.
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved.
ePlex Blood Culture Identification PanelsDriving the next phase of growth
Unique Assay Design
• 10-20% more organism coverage than comparable panels12-13
• Includes potentially fatal fungal organism C. auris
Rapid Actionable Results
• Results within two hours of confirming a bloodstream infection
• Appropriate therapy sooner with broadest resistance gene coverage
Software Integration Optimizes Patient Care
• Unique antimicrobial stewardship module
• Alert notifications help eliminate patient treatment delays
Instrument
Software v2.0
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 16
Investing in Innovation to Drive Sustained Long-Term Growth
2017 2018 2019 2020 2021+
RP Panel
FDA Clearance
BCID Panels
FDA Clearance CNS PanelIn Development
Instrument
Software v3.0
GI PanelIn Development
ePlex System
FDA Clearance
Ongoing Platform
Development and
Menu ExpansionSARS-CoV-2 EUA Clearance
RP2 PanelCommercial Launch
Instrument
Software v2.5
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 17
Accelerate BCID Launch and Extend RP Leadership
2020 Action Plan
Continue to focus on panel
utilization to accelerate revenue
Drive efficiency with optimized
commercial organization including
increases in Strategic Account
Team
Finalize contracts with leading
national IDNs and GPOs
BCID drove 80% of new customer
placements
> 300 new panels implemented
and pending implementation
Almost 50% of BCID placements
also include RP
2019 Accomplishments
1. XT-8 gross margin based on 2011-2016 results. Year 3 XT-8 gross margin results were 47% on a non-GAAP basis related to certain one-time charges
2. ePlex gross margin based on 2018-2020 results and may not be indicative of future performance
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 18
Drive ePlex Gross Margin Expansion
GenMark Product Gross Margin Trajectory
-30%
-20%
-10%
0%
10%
20%
30%
40%
50%
60%
70%
Year 1 Year 2 Year 3 Year 4 Year 5
ePlex
XT-8
History of driving significant
gross margin improvements
Improved ePlex gross margin by
5 points over Q3’19 to 39%
Goal to exit 2022 with 60%
ePlex gross margin
ePlex
Target
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 19
Deliver on Innovation Agenda
Deliver ePlex Menu
• Launched RP2 incorporating COVID-19
• Execute GI product development and clinical study
• Complete technology development for future panels
Elevate Manufacturing Capabilities
• Continuous improvement manufacturing processes
• Expanded ePlex manufacturing capacity to support demand
Leverage Technology and Commercial Execution
• Capitalize on market position within the broader strategic
landscape
Total Revenue
YoY
$38.7M
~80%
$40.1M
~118%
ePlex Revenue
YoY
$34.3M
~119%
$35.2M
~195%
20
2020 Quarterly Results
Q1 2020 Q2 2020
Net Placements
Installed Base
54 (109 gross)
581
71 (89 gross)
652
Gross Margin
YoY
41.6%
14.5 ppts
39.5%
3.7 ppts
Operating cash $47.1M $132.8M
~104%
Q3 2020
~187%
722
5.1 ppts
70 (86 gross)
$42.6M
$38.0M
38.8%
$137.3M
21
2020 Revised Guidance
Total Revenue
Gross Margin
Net Placements
Operating Expenses
$165 to $168 million
38% to 40%
230 to 250 net new analyzersAnnuity per ePlex Analyzer of $175 to $200 thousand
$70 to $75 million
Cash Usage (excl. Financing) $10 to $15 million
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved.
References
1. Upper Respiratory Infection (URI or Common Cold). Johns Hopkins Medicine. Retrieved from http://www.hopkinsmedicine.org/healthlibrary/conditions/pediatrics/upper_respiratory_infection_uri_or_common_cold_90,P02966/ (Date accessed: May 2017)
2. The Common Cold Fact Sheet. National Institute of Allergy and Infectious Diseases, National Institutes of Health. December 2004.
3. Fendrick A, et al. (2003) The Economic Burden of Non-Influenza-Related Viral Respiratory Tract Infection in the United States. Arch Intern Med 163(4):487-94.
4. Antigen detection, DFA, culture and batch PCR delay treatment decisions based on batch methods run once per day often excluding weekends.
5. CE-IVD RP Panel also detects Human Bocavirus, Middle East Respiratory Syndrome Coronavirus, Bordetella pertussis, Legionella pneumophila
6. ePlex RP package insert. After discordant resolution. May 2017
7. V2_Sepsis Fact Sheet. World Sepsis Day. Global Sepsis Alliance. Center for Sepsis Control & Care.
8. H-Cup Statistical Brief #204: May 2016
9. Institut Pasteur, Sepsis/Septicemia; https://www.pasteur.fr/en/medical-center/disease-sheets/sepsis-septicemia.
10. Kumar, et. al., Crit Care Med 2006 Vol. 34, No. 6. p. 1589-1596.
11. Review on antimicrobial resistance. Chaired by Jim O’Neill. Dec. 2014.
12. Potula, R., Dadhania, V., & Truant, A. L. (2015). Automated blood culture testing. MLO: Medical Laboratory Observer, 47(9), 8-14.
13. Analyses from GenMark clinical data and data from 5 US hospitals.
© Copyright 2020 GenMark Diagnostics, Inc. All rights reserved. 23
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