Q4 2018 Earnings Call March 7, 2019 - Investor Relations ...
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Q4 2018 Earnings Call • March 7, 2019
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 actually achieve the plans, intentions or expectations disclosed in our forward-
looking statements. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and
other factors that may cause our actual results, performance or achievements to be materially different from any future
results, performance or achievements expressed or implied by the forward-looking statements. The risks and
uncertainties that we face are described in our most recent filings with the Securities and Exchange Commission.
Except as required by law, we assume no obligation to update these forward-looking statements, even if new
information becomes available in the future.
This presentation will also include certain financial measures that were not prepared in accordance with U.S. GAAP.
The information required by the SEC pursuant to Regulation G, including reconciliation of the non-GAAP financial
measures to the most directly comparable GAAP financial measures, can be found in our earnings release issued
previously today, which is on our website.
2
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. Q&A
3
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 rate $37.6
900x • Launch SR-X, SP-X, CorPlex excludes one-time
sensitivity ECL pg/mL ~’00-’13
increase • EU Powering Precision Health Summit collaboration
revenue Q4
fg/mL ~’13-present +65%
Quanterix 30%
$22.9
44% Q3
59%
$17.6 Flat +61%*
Research Q2
Market: $1B $8B $12.2
Q4
Now: Rev 0 - $38M; Neuro and Onco +66%
Q4
Q3 Q1
300% +41%
increase in 1H
probability of Starting 2020: LDT – IVD - DTC Diagnostics
drug approval
Market: $30B+ 2015 2016 2017 2018
:
4
GM 47% 44% 44% 48%
FY2018 Growth is Accelerating Across All Segments
($ 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 $- Gr. -100%
100%
Revenue $37.6M, +65%, +60% excl 1 time
60% 25% Instruments $9.60 Gr. +45%
GM +410bp, +259bp adjusting 1 time Growth
37% Consumables $13.80 Gr. +83%
Consumable pull-through grew from 35% of list price FY’18
Revenue
in Q1 to 41% in Q4; FY 40% 32% Services $12.10 Gr. +58%
Instrument growth accelerated in 2H after 3 years of 6% Other $2.10 Gr. +100%
flat growth 100%
5
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% $1.2
128 0 4 71
104 $0.5 141
91 $3.8
37
192 53 9 96
56
$2.0
19 89 34 56 $0.2 45
30 43
12 39 $0.7
14 12
2015 2016 2017 2018 2015 2016 2017 2018 2015 2016 2017 2018 2015 2016 2017 2018 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
'16 '17 '17 '17 '17 '18 '18 '18 '18
Number of drug trial Revenue Growth % Consumable growth
projects completed
*Instrument segmentation
6
estimated based on
consumables sold
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
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 Acquired
+410bps
COMMERCIAL STRATEGY
Restore Diagnostics rights ACHIEVED
Add 20 Commercial HC 25 + INVESTORS, 60 all functions
PPH sponsorship PPH Europe Success
Pubs 275+ 409
23/, FDA Advancement Two Meetings; ODES
100% TOP PHARMA
10/10, 19/20 top; ~800+ trials R: $1B$8B; D: $30B
Market Expansion
Overachieved Achieving Marginal Risk High Risk 8
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 utilization
Only
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
10Competitive 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
11Transforming Medicine with Digital Biomarkers
Today: Invasive and Late Tomorrow: Non invasive and Early
12 12Simoa 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 trials.
(13)
31 Jan 2019
(6) 2016 NFL predicts clinical progression
in pre-symptomatic Alzheimer’s
2015
This image cannot currently be displayed.
disease 16 years before onset.
2014
2012 2013 2x winner
13Simoa 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 14Neurology 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-reviewed pubs
• Strong network of world-leading KOLs
CAGR 67%
150 • Inbound FDA interest (Nf-L); recent breakthrough
device exemption for AB40/42 mass spec test for
100 Alzheimer’s
• Media, patient advocacy, and public attention to
50 promise of blood-based neurology tests (CNN,
Forbes, Bloomberg, Washington Post, GMA, etc.
0 • Deep adoption by leading academic and pharma
Pubs Markers Instruments
2015 2016 2017 2018
15Neurofilament 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 neuroaxonal damage and
PubMed Citations
NFL?
100 have prognostic value. Our results
support the utility of blood NfL as
80
an easily accessible biomarker of
60 disease evolution and treatment
40 response.
20
0 Editorial
2000 2002 2004 2006 2008 2010 2012 2014 2016 2018
Neurofilament light chain:
An important step toward
Publication Year
a disease biomarker in
multiple sclerosis
Source: Health Advances analysis, PubMed.
Page 451 16>$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 Programs
20 Oral
SNY, 11% 2017
15
12
$22B
10
5 NVS, 15%
0 TEVA, 17%
Phase I Phase II Phase III OTHERS
Abby 0.3%
Phase of Development
*Excludes non-industry sponsored trials, active-not yet recruiting, enrolling by
invitation, or unknown status trials
Source: Health Advances commissioned research, 2018
17Simoa 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 Biomedicine, Univ Hospital Basel,
3 Basel
Dr. Zuzanna Switzerland
Dr. Katja Akgün Neuroimmunological lab, Center of Clinical
4 Dresden
Dr. Ziemssen, Tjalf Neuroscience, Dresden, Germany
Prof. Kaj Blennow Clinical Neurochemistry Lab, Mölndal Hospital,
5 Gothenburg
Prof. Henrik Mölndal, Sweden
Prof. Wolfgang Institut für Neuropathologie, Universitätsmedizin
6 Göttingen
Dr. Niels Kruse Göttingen, Germany
Dr. Lucia Bianchi Dept of Neuroscience & Trauma Blizard Institute
7 London
Prof. Gavin Queen Mary Univ of London, UK
Dr. Amanda The DRI Fluid Biomarker Laboratory at University
8 London
Prof. Henrik College London, United Kingdom
9 Mainz Prof. Stefan Bittner Klinik für Neurologie, Universitätsmedizin Mainz,
Dr. Comi Giancarlo Clinical Neuroimmunology Unit - Institute of
10 Milan
Prof.Roberto Furlan Experimental Neurology, MIlan, Italy
Prof. Markus Otto
11 Montpellier Hôpital St Eloi, Montpellier, France
Dr. Patrick Oeckl
Prof. Markus Otto
12 Ulm University of Ulm, Ulm, Germany
Dr. Patrick Oeckl
Dr. Ruturaj
13 Bethesda National Institutes of Health, Bethesda, MD
Dr. Bibi Bielekova
Dr. Simon Thebault MS Clinical Ottawa Hospital University of Ottawa,
14 Ottawa Dr. Freedman, Mark
Ottawa ON Canada
Dr. Booth, Ronald
Dr. Marcus Handy Perelman School of Medicine, University of
15 Philadelphia
Dr. Amit Bar-Or Pennsylvania, Department of Neurology, Philadelphia,
Kevin Hrusovsky
16 Lexington Quanterix Corp, Lexington MA
Dr. David Wilson
Dr. Matthew
17 Framingham
Dr. Martin Kramer
Sanofi Genzyme, Framingham MA 18Simoa: 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: 9.4%
Run #:
Gothenburg
Philidelphia
Montpellier
Barcelona
Bethesda
Dresden
Ottawa
Gottingen
Quanterix
Site:
Mainz
Basel
Sanofi
Milan
AMS
Ulm
London QMUL
London UCL
MS sample #
19Emerging 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 onset: 34 yrs; avg. life expectancy after onset: 30 yrs
• Drug efficacy monitoring • Standard of care: MRI 1-2X/yr
• Relapse/severity prognostic • NfL as MRI replacement: 3.5M tests/yr
Majority of published data obtained with Simoa NfL Clinical Vaildation of NfL for MS is a Key Beachhead
20Digital 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
annual blood test blood test to diagnose with less dosing / toxicity.
Blood test monitors
progression
21QTRX Taking Aim at Alzheimer’s Disease with Simple Blood Test
22Blood Test May Detect Alzheimer’s In Patients 16 Years
Before Symptoms Appear
23Simoa: 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 Ab42:40 ratio
0.14
0.20
0.15
0.12
0.10
0.10 0.05
0.06 0.10 0.14 0.18 0.22 0.08 0.10 0.13 0.15 0.18
CSF Ab42:40 ratio plasma Ab42:40 ratio
1. Ovod et al. Alzheimers Dement.August ; 13(8): 841–849 (2017)
2. Thijssen et al, AAIC 2018 24Simoa: 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 25Poised 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 / Health Holy Grail
400+ pubs
4 Validation: 19/20 top pharma, PPH, 800+ trials Proven
All Areas
Product Rapid
5 Growth & Value; Razor – razor blade, $150M invested
execution Launches Growth
6 Low Risk / Solid Return + Uber Return Prospect Retail
7 Track Record for Commercializing Disruption Lynchpin
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