keeping up with covid - one company's story“
TRANSCRIPT
complexity simplified. 2
LUMINEX CORPORATION: FULLY EMBEDDED IN GLOBAL BIOMEDICAL SCIENCE AND HEALTHCARE ENTERPRISES
Actionable solutions across the biomedical spectrumLuminex is a biotech company providing molecular, proteomic, and cellular analysis tools and tests to life science and diagnostics markets exceeding $12B per year.
We seek to enable labs around the world to quickly advance science and deliver
beneficial, cost-effective healthcare solutions
complexity simplified. 3
LUMINEX CORPORATION: WHO WE ARE
• Differentiated platforms and assays, supported by 850+ patents, to address the needs of our clinical, biopharmaceutical, and research customers
• Enabling molecular, proteomic and cellular analysis
DIVERSIFIED SOLUTIONS
• Serving a growing $12B+ global life science marketplace
• Flexibility in reaching customers through direct sales, strategic partnerships, and other channels
ATTRACTIVE MARKETS
• Healthy profitability, increasing quarterly dividend, consistent cash flow and strong balance sheet
• ~25,000 instruments worldwide driving 75% annuity revenue
FINANCIAL STRENGTH & GLOBAL REACH
complexity simplified. 4
WE HELP LABS OBTAIN ANSWERS TO CHALLENGING MEDICAL QUESTIONS BY PROVIDING SOLUTIONS FOR DIAGNOSTIC AND RESEARCH PURPOSES.
OUR STORY
2001 2005 2007200019991995
2021
2009 2010
2019
2008
202020162015201320122011 2017
Luminex Corporation Founded
Austin, TX
Luminex® 100™Launched
Luminex CorporationGoes Public
First xMAP® ProductIVD Cleared
Luminex® 200™ Launched
xTAG® CysticFibrosis KitsIVD Cleared
TM BioscienceAcquisition
xTAG® RespiratoryViral Panel
IVD ClearedFLEXMAP 3D®
LaunchedMAGPIX®
Launched
Eragen Biosciences Acquisition
GenturaDxAcquisition
xTAG GastrointestinalPathogen Panel
xTAG® CYP2D6 &CYP2C19 Assays
IVD Cleared
ARIES® SystemARIES® HSV 1&2 Assay
IVD Cleared
NxTAG® Respiratory Pathogen
Panel IVD Cleared
ARIES® M1 SystemARIES® Flu A/B & RSV Assay
IVD Cleared
Nanosphere Inc. Acquisition
ARIES® Bordetella AssayARIES® C. difficile Assay
ARIES® GBS AssayARIES® Group A Strep
IVD Cleared
ARIES® Norovirus CE-IVD Cleared
Acquisition of MiliporeSigma'sImage-Based
Flow Cytometry Portfolio
ARIES® MRSA Assay IVD Cleared
NxTAG CoV Extended Panel (EUA)
VERIGENE® II System IVD Launch; xMAP® INTELLIFLEX
System RUO Launch;Multiple Additional SARS-
CoV-2 Assay Launches
ARIES® SARS-CoV-2 Assay (EUA)xMAP® SARS-CoV-2
Multi-Antigen IgG Assay (EUA)
complexity simplified. 5
DEVELOPING SOLUTIONS DURING THE COVID -19 PANDEMIC
PCR-BASED TESTS
5
• Two Luminex PCR-based COVID-19 tests have already received EUA clearance
• Run on ARIES and NxTAGSystems
• Expecting EUA clearance on NxTAG RPP+SARS-CoV-2 Assay any day
• ARIES A/B & RSV + SARS-CoV-2 Assay EUA submission is ready to go to FDA
• Planning for EUA submission to FDA for VERIGENE II RSP Flex Assay later this quarter
ANTIBODY-BASED TESTS
• xMAP Multi-Antigen IgG assay has received EUA clearance
• Developing additional antibody tests to help identify individuals who may have some level of immunity to the virus
• Anticipate submitting EUA submission to FDA for xMAP-based Neutralization Assay in Q2 ‘21
complexity simplified. 6
MULTIPLE COVID-19 SOLUTIONS FOR THE LONG RUN
Note: Figures are total assay and system revenue
Molecular Testing
Serology Testing
Vaccines/ Therapeutics/ Cell Research
L O N G T E R M :
ARIES® • Targeted, sample-to-answer diagnostic testing
VERIGENE® • Syndromic, sample-to-answer diagnostics and surveillance
MAGPIX®
• Syndromic, high-throughput, cost-effective diagnostic testing
• SARS-CoV-2 serology testing for immunity monitoring, vaccine development
LUMINEX® 200™
FLEXMAP 3D®
• High-throughput, multiplex serology, cytokine & proteomic research
xMAP®
INTELLIFLEX
• High-throughput, multiplex serology research
• Vaccine, therapeutic, cytokine & proteomic research
S H O R T / M I D - T E R M : R E S E A R C H , T H E R A P E U T I CS A N D V A C C I N E S H E L P L O W ER T H E C U R V E
D I A G N O S T I C S A N D S E R O LO GY H E L P F L A T T E N T H E C U R V E
complexity simplified. 7
SARS-CoV-2 MDx PROJECTS
VERIGENE® II RSP Flex + SARS-CoV-2 (EUA)• Built on RP Flex panel• 3 gene CoV target add to PCR
tube 4• Finalizing submission package
VERIGENE® II RSP Flex + SARS-CoV-2 (RUO) • Launch planned for Q2 ‘21
VERIGENE® II RSP Flex + SARS-CoV-2 (CE-IVD)• Launch planned for Q3 ‘21
VERIGENE® SARS-CoV-2 (EUA)• Pooling claim (5 samples)• LoD of 100 copies/ml• Submitted in Jan ‘21• Reprioritized by FDA
* Biosurveillance recommendations
NxTAG® RPP v2 (IVD)• Includes updated Flu and other
targets*• Submitting for EUA in March
ARIES® SARS-CoV-2 Assay (EUA, CE-IVD and LDT)
NxTAG® CoV Extended PanelNxTAG® RPP+SARS-CoV-2 (CE-IVD)
VERIGENE® SARS-CoV-2 AssayNxTAG® RPP + SARS-CoV-2 Panel
ARIES® Flu A/B & RSV + SARS-CoV-2 (EUA)• Uses Taqman for improved
MFG• Submitting for EUA 2/25
ARIES® Flu + SARS-CoV-2 Fast• Tech Feasibility underway for
~60-75 min version
complexity simplified. 8
xMAP® SARS-CoV-2 MULTI-ANTIGEN IgG ASSAY
Detects IgG antibodies against 3 SARS-CoV-2 antigens, providing comprehensive results:
• S1 subunit of the spike protein
• Receptor Binding Domain (RBD) of the spike protein
• Nucleocapsid protein
complexity simplified. 9
EXPANDED MANUFACTURING TO MEET INCREASED DEMAND
Chicago/VERIGENE®
• ~25% increase in footprint ($8M facility purchase). Q1 2021
• 600K test capacity (VERIGENE II fully automated lines)
• 1.2M test capacity (VERIGENE I)
• $3.4M total investment (already paid)
Madison/Reagents
• 10%+ increase in building footprint (investment of $2.5M)
• Supports both ARIES® and VERIGENE II
Austin/ARIES®
• 600K test capacity. Beginning of 2020
• 1.6M test capacity. Summer 2020
• 3.2M test capacity (investment of ~$5M). Ready now!
• 4.5M test capacity (investment of $1M). Mid-2021
• 6M+ test capacity (investment of ~$5M). Beginning of 2022
• 50K sq ft facility expansion. Mid-2021
Toronto/NxTAG®
• 1M test capacity. Beginning of 2020
• 9M test capacity (investment of $500K). Summer 2020