Slide 1: Q4 2018 Earnings Call • March 7, 2019
Q4 2018 Earnings Call • March 7, 2019
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains “forward-looking” statements that are based on our beliefs and assumptions and on information available to us as of the date of this presentation. Forward-looking statements include all statements that are not historical facts. We may not actuall
Slide 3: Today's Agenda
Today’s Agenda I. Strategic and Financial Progress – Kevin Hrusovsky – Chairman, CEO i. Q4 and FY 2018 Highlights ii. 2018 / 2019 Goals & Priorities iii. Transforming Medicine: Neurology Momentum Update II. Financial Report – Joe Driscoll – CFO III. Summary of QTRX Opportunity - Kevin Hrusovsky IV.
Slide 4: Massive Market Opportunity, Disruptive Technology and a Track Record for Execution
Massive Market Opportunity, Disruptive Technology and a Track Record for Execution Exquisite Biomarker Sensitivity Superb Execution Total QTRX Revenue Growth • Aushon acquisition • Regained IVD rights ($ in millions) • Attracting Top Talent 60%* ELISA ng/mL ~’75-’90’s • Two FDA Nf-L sessions *Growth
Slide 5: FY2018 Growth is Accelerating Across All Segments
FY2018 Growth is Accelerating Across All Segments ($ in millions) 65% Revenue $10.9M, +65% vs. PY Q4 Growth 33% Instruments $3.60 Gr. +106% High margin mix accelerating, Consumables growth Q4’18 Consumables Gr. +67% +67%; GM 48.2%, +450bp 36% $3.90 Revenue 31% Services $3.40 Gr. +52% 0% Other $-
Slide 6: Scientific Research is Driving Brand Awareness, Performance and Utilization
Scientific Research is Driving Brand Awareness, Performance and Utilization PUBLICATIONS MARKERS ACCELERATOR INSTRUMENTS* CONSUMABLES # of units: bars $M of sales 100% Other 278 Oncology 45 Neurology $3.9 $1.0 409 45 $3.4 259 46% 176 $2.4 190 5% 18 22 206 $0.6 88 120 $1.7 133 175 $6.7 -2% 14 211 6%
Slide 7: FY2018 Growth Stratification
FY2018 Growth Stratification Geography Customer Diseases 1% 9% 7% 23% 31% 47% 53% 60% 69% Growth Growth Growth Neurology +73% NA +64% Pharma/Biotech CRO +63% } 92% Europe +69% Academia Oncology +110% +69% Asia +54% Cardiology +242% ID +101% 7
Slide 8: 2018 Investor Targets and Catalysts
2018 Investor Targets and Catalysts FINANCIALS NEW PRODUCTS METRIC STATUS METRIC STATUS Revenue: 40% growth SR-X 50 >70 booked +65% Instrument +20% SP-X 6+ plex prototype Q4 test bed 10 plex >46% Annual Utilization: 33% List Price 25 new assays 69+ 40% List GM: +300bps. CLIA Lab for Pharma Aushon Ac
Slide 9: 2019 Targets & Growth Catalysts
2019 Targets & Growth Catalysts LSR Neurology LSR Oncology Enter diagnostics: Financials: Continue high double 3x larger than Neuro 1. 50 Drug Trials Long-term growth: 40% digit growth w/ high w/ minimal (neuro/onco) utilization penetration today Utilization: Drive 2. LDT partner incremental utiliza
Slide 10: Simoa: Technology and Instrumentation
Simoa: Technology and Instrumentation 100x Sensitivity Target by 2021 Sensitivity & Assay Precision HD-1 SR-X HD-X SP-X (2014) (2018) (2H 19) (1H 19) Fluorescence Chemiluminescence Beads Planar 10
Slide 11: Competitive Landscape
Competitive Landscape Bead-Based Planar SP-X Bead-based Erenna Electrochemi- Technology ELLA Simoa Simoa Immunoassay Immunoassay luminescence Sensitivity Dynamic Range Automation & Ease of Use Precision Multiplexing Menu Cost 11
Slide 12: Transforming Medicine with Digital Biomarkers
Transforming Medicine with Digital Biomarkers Today: Invasive and Late Tomorrow: Non invasive and Early 12 12
Slide 13: Simoa Neurology Publications – Catalyzing Disruption
Simoa Neurology Publications – Catalyzing Disruption Drug Clinical Trials Using NfL Alzheimer's Disease TBI/concussion Multiple sclerosis 2X Parkinsons, ALS, FTD, etc 2019 (176) 2018 (78) 08 Feb 2019 Spinal NFL clinically validated for taps (41) 2017 monitoring MS & treatment response in 2 Phase III
Slide 14: Simoa Neurology Publications – Catalyzing Disruption
Simoa Neurology Publications – Catalyzing Disruption Breaking in 2019: 31 Jan 2019 NFL predicts clinical progression in pre-symptomatic Alzheimer’s Publications disease 16 years before onset. Will NFL Save the “Concussion” NFL? 2013 2014 2015 2016 2017 2018 Publication year 14
Slide 15: Neurology Momentum Fueling Growth and Future Strategy
Neurology Momentum Fueling Growth and Future Strategy • Strongest growth in neurology RUO franchise with Neurology Momentum accelerating publications 2018 250 • Nf-L, amyloid beta, tau, and other markers CAGR 67% showing tremendous potential for key clinical CAGR 139% 200 applications in top peer-re
Slide 16: Neurofilament Light in Research Studies Accelerating Rapidly
Neurofilament Light in Research Studies for MS and Other Neurological Conditions Accelerating Rapidly RESEARCH PUBLICATIONS ON NFL 160 Abstract: Neurology 2019: Blood Will NFL NfL levels are associated with clinical 140 “Concussion” Save the and MRI-related measures of disease 120 activity and neuro
Slide 17: >$22B Spent Annually on MS Drugs with Active Clinical Trials
>$22B Spent Annually on MS Drugs with 62 Active Clinical Trials MULTIPLE SCLEROSIS CATEGORY MARKET SHARE BY & MULTIPLE SCLEROSIS* THERAPIES IN DEVELOPMENT SALES N=62 Drug Trials Others, 5% Estimate 10 already using sNF-L RHHBY, 4% Merck KgaA, 30 9% Other 26 24 25 Injectable BIIB, 39% Development Pro
Slide 18: Simoa NfL Multicenter Analytical Validation
Simoa NfL Multicenter Analytical Validation - 17 sites across Europe and North America Location Investigator Study Site 1 Amsterdam Dr. Charlotte Neurochemistry Laboratory, Amsterdam University 2 Barcelona Dr. Manuel Laboratori de Neuroinmunologia Clinica Centre Prof Jens Kuhle, Department Biomedici
Slide 19: Simoa: NfL Multicenter Validation – Assay Consistency
Simoa: NfL Multicenter Validation – Assay Consistency Multiple Sclerosis Sample Results – all sites Assay reproducibility – all sites 9 common MS Serum QC samples CVs across samples tested Site: 85 assay runs all data: at each site N = 255 each level 7.2% 6.3% NfL, pg/mL 7.1% Avg CV between sites: 9
Slide 20: Emerging Clinical Biomarker: Neurofilament Light (NfL)
Emerging Clinical Biomarker: Neurofilament Light (NfL) NFL PUBLICATIONS WW DISEASE INCIDENCE (MILLIONS) 25 2015 60 2016 20 50 2017 40 2018 15 30 20 10 10 5 0 0 Parkinsons FTD ALS Alzheimers TBI MS STUDIES CONFIRM NFL CLINICAL UTILITY: MULTIPLE SCLEROSIS: • Disease activity monitoring • Avg. age of o
Slide 21: Digital Biomarkers Disruption Paradigm: Alzheimer's Disease Opportunity
Digital Biomarkers Disruption Paradigm: Alzheimer’s Disease Opportunity Today Alzheimer’s disease not Imaging expensive and often Therapies for later stage diagnosed until symptoms not covered disease have limited effectiveness Tomorrow Detect or screen in Follow on Image or Therapy delivered sooner
Slide 22: QTRX Taking Aim at Alzheimer's Disease with Simple Blood Test
QTRX Taking Aim at Alzheimer’s Disease with Simple Blood Test 22
Slide 23: Blood Test May Detect Alzheimer's In Patients Years Before Symptoms Appear
Blood Test May Detect Alzheimer’s In Patients 16 Years Before Symptoms Appear 23
Slide 24: Simoa: Potentially Superior to Mass Spectrometry for Plasma Amyloidosis Detection
Simoa: Potentially Superior to Mass Spectrometry for Plasma Amyloidosis Detection ROC analysis on similarly powered preliminary studies Mass spectrometry1 Simoa2 AUC = 0.89 AUC = 0.95 Amyloidosis (n = 18) Amyloidosis (n = 17) Control (n = 23) Control (n = 18) 0.30 0.16 0.25 Plasma Ab42:40 ratio CSF
Slide 25: Simoa: In the News
Simoa: In the News PPH 2018 - Amsterdam February 2019 31 Jan 2019 NfL predicts clinical Comment ABC – Feb 2019 progression in pre-symptomatic Could MS be Alzheimer’s disease 16 years diagnosed with a before onset simple blood test? Bloomberg Radio Feb 2019 25
Slide 26: Poised to Disrupt Healthcare and Create Significant Value
Poised to Disrupt Healthcare and Create Significant Value Differentiator Value Best in 1 Category-defining; Unrivaled Sensitivity / Technology Disrupt Class 2 $3B to New Methodical market penetration strategy to reward investors $38B Answers market 3 DNA – RNA - Protein; Better linked to Disease / H