transforming transfusion diagnostics, and beyond
TRANSCRIPT
TRANSFORMINGTRANSFUSIONDIAGNOSTICS,AND BEYOND.Franz Walt, CEO
Jeremy Stackawitz, President
Ed Farrell, President
Chris Lindop, CFO
March 4th, 2019
Safe Harbor Statement
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 2
This presentation contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act
of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-
looking statements include statements regarding our expectations of continued growth,
the development, regulatory approval, commercialization, and impact of MosaiQ and
other new products (including our current expectations regarding the timing of MosaiQ
project milestones) and forecasts of the demand for MosaiQ Microarrays and our
expected sources of funding. Such statements are based on current assumptions that
involve risks and uncertainties that could cause actual outcomes and results to
differ materially.
These risks and uncertainties, many of which are beyond our control, include delays
or denials of regulatory approvals or clearances for products or applications;
market acceptance of our products; the impact of competition; the impact of facility
expansions and expanded product development, clinical, sales and marketing
activities on operating expenses; delays or other unforeseen problems with respect
to manufacturing, product development or field trial studies; adverse results in
connection with any ongoing or future legal proceeding; continued or worsening
adverse conditions in the general domestic and global economic markets; as well as
the other risks set forth in the company's filings with the Securities and Exchange
Commission (“SEC”). Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof. Quotient
disclaims any obligation to update these forward-looking statements.
The Quotient logo and MosaiQ are registered trademarks or trademarks of Quotient
Limited and its subsidiaries in various jurisdictions. Any images, schematics or other
graphic or pictorial representations contained herein, including those representing
the MosaiQ™ Instrument or Microarrays, are for illustrative purposes only. Those
representations may change and may not accurately represent final Quotient products
or services.
This presentation contains statistics and other data that in some cases have been
obtained or compiled from information made available by third parties. Quotient makes
no representation or warranty, expressed or implied, with respect to the accuracy,
reasonableness or completeness of such information.
A shelf registration statement relating to the ordinary shares was filed with the SEC
and is effective. We will also file a prospectus supplement with the Sec for the
offering to which this communication relates. Before you invest, you should read the
prospectus in that registration statement, the prospectus supplement, and other
documents the issuer has filed with the SEC for more complete information about the
issuer and this offering. You may get these documents for free by visiting EDGAR
on the SEC website at www.sec.gov. Alternatively, the issuer, the underwriters, or
any dealer participating in the offering will arrange to send you the prospectus if you
request it by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus
Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at
(877) 547-6340 or by email at [email protected]; or Cowen
and Company, LLC, by mail at Cowen and Company, LLC, c/o Broadridge Financial
Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus
Department, or by telephone at (631) 274-2806.
STRATEGY
COMMERCIAL
TECHNOLOGY
FINANCE
Q&A
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 3
AGENDA
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 4
STRATEGY
Quotient
Eysins, Switzerland
Global headquarters & center of competence for MosaiQ microarray manufacturing
Edinburgh, United Kingdom
Center of competence for Alba reagent business and
product development for both reagent and MosaiQ microarray development
Newtown, Pennsylvania, USA
US Commercial base
History
1990: Scottish National Blood Services creates National Reagents Unit
1998: Diagnostics Scotland (later renamed Alba Bioscience)
created from merger of NRU and Scottish Antibody Production Unit
2007: Quotient founded and acquired Alba Bioscience
2014: Quotient Suisse SA formed & Quotient IPO on Nasdaq
2018: 72 reagents products CE marked and 63 FDA licensed/cleared
MosaiQ factory ISO certified and instrument CE marked
Over 30 years’ heritage in transfusion Dx
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 5
Milestones
Jun 2018 ✓
– Successful clinical trials (Initial IH)
– Senior notes issuance completed
Sep 2018 ✓
– EU submission of Initial IH
– MosaiQ instrument CE marked
Oct 2018 ✓
– Allan Robb Campus certified ISO 13485 under MDSAP (EU)
– Full FDA licensure (US)
Dec 2018 ✓
– Senior Notes restructured
– Raised $65m of new equity capital
– Eysins facility ISO 13485 certified
– V&V for initial SDS Microarray completed
Jan 2019 ✓
– Consolidation on Allan Robb Campus completed
– Publication of successful Expanded IH data
– Initial SDS field trial commenced
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 6
Consistently delivering on our commitments
Transfusion Dx marketAttractive $3.4 billion* market growing low single digit
The MosaiQ™ system is not yet commercially available or approved by any government agency.
*Source: Estimate based on BCC Research, The Global Blood Industry, March 2015
Donor Testing 2/3
– Concentrated customer base
– High test volume per customer
Patient Testing 1/3
– Fragmented customer base
– Low test volume per customer
SDS: $875m
MDS: $1,100m
IH: $325m
IH: $1,100m
March 2019 7
Transfusion Dx playersFragmented market with many highly specialized players
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 8
IH MDS
Source: Independent global consulting analysis commissioned
by Quotient and Quotient’s own internal analysis
SDS
Transfusion Dx playersMosaiQ has the potential to cover all with one technology
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 9
MDS
SDS
Source: Independent global consulting analysis commissioned
by Quotient and Quotient’s own internal analysis
IH
MosaiQ value proposition1) One technology covering all testing needs
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 10
Serological
Disease
Screening
Antibody
Screen/ID
Molecular Disease
Screening
Manual
Testing
Blood
grouping
MosaiQ value proposition1) One technology covering all testing needs
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 11
Manual Testing
MDSExpanded SDS
SDS (CMV & Syphilis)
Blood grouping
MDSSDS
Expanded IH & initial SDS
Blood grouping only
MosaiQ value proposition2) Automation helps to address shortage of qualified staff
Sources: Number of tests based on Genetic Testing Registry Data in National Center for Biotechnology Information [NCBI], https://www.ncbi.nlm.nih.gov/gtr/
Workforce calculation based on total number of Medical and Clinical Laboratory Technologists and Technicians jobs (Bureau of Labor Statistics [BLS], 2018)
Source: Mounting shortage of medical lab techs hurts most in rural Alberta, expert says 4 April 2017
.
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 12
300000
315000
330000
345000
360000
375000
10000
20000
30000
40000
50000
60000
2013 2014 2015 2016 2017
Nu
mb
er
of
tes
ts
Wo
rkfo
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[…] Canada’s aging population
is creating an increased demand
for lab tests, including blood
and DNA tests.
[…]. But with too few graduates
to fill the positions opening as older
workers retire in the coming years, the
problem is going to get worse,
[…] According to CSMLS, almost
50 per cent of its members
will retire over the next 10 years.
MosaiQ value proposition3) Better workflow leads to better cost position addressing budget constraints
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 13
Total costs of ownership
Current practice
Direct testing costs
Non-direct testing costs
MosaiQ
Direct testing costs
Better cost position
Non-direct testing costs
MosaiQ value proposition4) Comprehensively characterized blood is a better and safer product
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 14
Standard characterised
bag of blood
Comprehensively characterized
bag of blood
*Throughput and footprint based on publicly available data and targeted MosaiQ performance
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 15
MosaiQ 125
PK 7300
Erytra
Vision MAX
IH 1000
Neo Iris
2,875
2,400
800
690
720
N/A
1,863
1,491
1,039
527
488
N/A
MosaiQ value proposition5) Highest throughput and productivity per m²
Company & Instrument Throughput (Tests/h) Productivity ((Tests/h)/m2)
Expanded IH
MosaiQ value proposition5) Highest throughput and productivity per m²
*Throughput and footprint based on publicly available data and targeted MosaiQ performance
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 16
Company & Instrument
MosaiQ 125
PRISMnEXT
PK 7300
Cobas e801
Vitros 3600
Architect i400SR
Throughput (Tests/h) Productivity ((Tests/h)/m2)
1,125
960
600
300
189
400
729
490
370
178
100
98
Expanded SDS
MosaiQ value proposition5) Highest throughput and productivity per m²
*Throughput and footprint based on publicly available data and targeted MosaiQ performance
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 17
Company & Instrument
MosaiQ 125
PRISMnEXT
PK 7300
Throughput (Tests/h) Productivity ((Tests/h)/m2)
2,000
800
960
1,296
490
490
Expanded IH + Expanded SDS
Erytra
PRISMnEXT
Neo Iris
Portfolio roadmapBroad pipeline for transfusion Dx and beyond
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 18
Transforming transfusion diagnostics and beyond Potential in immunomicroarray and MDx
Source: Independent global consulting analysis commissioned by Quotient
The MosaiQ™ system is not yet commercially available or approved by any government agency.
Value propositionMosaiQ
Simplified workflow
Ability to combine test
modalities
High-throughput capabilities
Lower sample volume
requirements
Versatile chip printing and test mixing
Suited to immunomicro-array and MDx
Potential for reduced
costs
Highly automated and user friendly
Up to 132 probes per cartridge
(incl. controls)
Ability tohandle
differentliquid sample
types
MosaiQ offers a simple
and automated workflow
for high-throughput
immunomicroarray and
MDx tests
One sample, many tests
Consolidate multiple
testing platforms with
a single technology
Simplified workflow /
cost savings
Application
Current focus on blood transfusion:
estimated $3.4bn market (in 2015)
MosaiQ has the potential to be used
more broadly within immunomicroarray
(IA) and molecular diagnostics (MDx)
IA and MDx:
– c.32% (IA) and c.10% (MDx) of IVD market
– among the fastest growing segments
– forecasted to reach c.$40bn by 2023
An independent consulting firm was engaged to identify opportunities in IVD beyond the transfusion space
March 2019 19
Numerous opportunities evaluatedSeven Dx areas identified with significant commercial potential and fit
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 20
Shortlist of opportunitiesPreliminary screenPotential opportunities
16 TAs relevant to
immunoassay and MDx
Within each TA, identified major
patient situations requiring
frequent laboratory testing to
identify testing opportunities
leveraging MosaiQ’s core
modalities (IA and MDx)
Triaged long list of opportunities
to exclude those less amenable
to the MosaiQ platform if:
consisting of single tests
involving very low volumes
with low technical or
commercial feasibility*
currently pursued by
MosaiQ or in partnerships
Identification of opportunities
Relevant therapeutic areas
Shortlisted opportunities based on:
Commercial potential:
market size of relevant segment
level of addressable need
Suitability to MosaiQ:
suitability of testing modalities
breadth of test menu
extent of panel opportunities
56 potential opportunities
40 opportunities relevant
to MosaiQ platform Shortlist of 7 opportunities
across 5 TAs
Source: Independent global consulting analysis commissioned by Quotient
Deep dive into seven opportunitiesAbility to win: commercial attractiveness and technological fit
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 21
Therapeuticarea Opportunities
AllergyPresentation-specific allergy testing
and component testing panels
Infectious disease High-throughput diagnostic and monitoring panels
Reproduction and women’s health Pregnancy monitoring panels
Autoimmune disease
Disease-specific diagnosticpanels
Disease-specific monitoringpanels
Transplant medicine
Pre-transplant testing
Post-transplant recipient monitoring panel
Refined opportunities selected for in-depth analysis In-depth assessment of opportunities
Co
mm
erc
ial
att
racti
ven
ess
Co
mp
eti
tio
nA
bil
ity t
o w
in
Commercial size
Commercial feasibility
Key players
MosaiQ’s value
proposition and suitability
Requirements
for success
COMMERCIAL
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 22
Ready for innovation and change
Experts’ points of view
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency.
Mr B Block
BCA
23
Increasing complexity
Multiple instruments
Inefficient workflow
Lack of innovation
Prof M Schmidt
German Red Cross
Dr P Williamson
CTS
Dr E Castro
Valencia, Spain
MosaiQ is designed to meet customers’ needs
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 24
300000
315000
330000
345000
360000
375000
10000
20000
30000
40000
50000
60000
2013 2014 2015 2016 2017
Nu
mb
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of
tests
Wo
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rce
Innovation, consolidating testing, improving workflow, reducing complexity
MosaiQ
Direct testing costs
Better cost position
Non-direct testing costs
MosaiQ impacts multiple areas in the donor center
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 25
Delivering lower total cost per donation from vein to vein
CollectionSamples
ReceptionSorting Testing
Product
ReleaseInventory
Preparing the market for adoption
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 26
Contacts 250
Accounts 125
Opportunities 75+
Countries represented 20
Hypercare sites
planned for 20198
Tenders in which we
plan to participate
in the next 12 months
15+
Customers engaged and identified
Hypercare launch plan
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 27
6 countries & 8 donor testing facilities
Site +1 +2 +3 +4 +5 +6 +7 +8 +9 +10 +11 +12 +13 +14
Customer 1 ITT
Customer 2 ITT
Customer 3 ITT
Customer 4 ITT
Customer 5 ITT
Customer 6 ITT
Customer 7
Customer 8
Instrument Installation Testing by Customer Influenced ITT
Month following commercial product availability
Preparing the market for adoption
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 28
We are engaged with the market and ready to launch
World-class advisory board ✓
Clinical trial experience and plans ✓
Commercial organization ready ✓
High customer awareness ✓
Hypercare launch planned ✓
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 29
TECHNOLOGY
Development history
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 30
Manufacturing site and instrument completed, now focusing on content development
Manufacturing
Instrument Microarray
Immunohematology (IH)Comprehensive menu on track
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 31
Expanded Antigen Microarray Performance
Concordance data were achieved in sample sizes
of between 120 to 280:
Blood Group
Antigen
A B D C c E e K K Cw
Concordance 100% 100% 100% 100% 100% 99.6 100% 100% 100% 100%
Blood Group
Antigen
Kpa Fya Fyb Jka Jkb M N S Leb
Concordance 100% 99.5% 100% 100% 100% 100% 99.1% 99.4% 100%
Serological Disease Screening (SDS)Field trial ongoing
In this V&V study, a total of 1261 samples were tested.
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 32
Initial internal SDS Performance
Pathogen Sensitivity % Specificity %
CMV 98.5% 98.8%
Syphilis 100.0% 99.9%
Molecular Disease Screening
The MosaiQ™ system is not yet commercially available or approved by any government agency. 33
Unique proprietary approach to molecular testing
NeutrAvidin-Gold
Amplification (PCR)
Overhang sequence DNA sequence (antisense)
Biotin
5’3
’
3’ 5’
Enriched target
Universal Array
Plasma sample
Cell lysis
Detection
Target amplicon
March 2019
Probe A Probe B Probe C
Molecular Disease Screening
The MosaiQ™ system is not yet commercially available or approved by any government agency. 34
The complementary oligo system works
March 2019
tA-WNV
tB-WNV
tC-WNV
tD-WNV
Molecular Disease Screening
The MosaiQ™ system is not yet commercially available or approved by any government agency. 35
Successful multiplex detection of six targets
March 2019
Single digit copy per 500µL
NegativePositive
FINANCE
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 36
$400 million of capital invested in the last 7 years
Source of funds ($m) Use of funds ($m)
More than $107 million in available cash at end of third quarter
Equity, $385
Dept, $120
Capital & Equipment, $104
R&D MosaiQ Instrument, $21
R&D MosaiQ Microarray, $177
R&D Reagents, $12
Corporate Costs, $39
Debt Service, $37
Increase in cash resources, $115
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 37
Indicative reagent spend
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 38
Illustrative average reagent spend for expanded IH and SDS menu on a microarray equivalent basis
Current Reagent Spend per Donation North America EU
Immunohematological Testing $ 8.00 $ 6.00
Serological Disease Screening $ 12.00 $ 8.00
Molecular Disease Screening $ 15.00 $13.00
$ 8.00
Microarray dollar unit cost at 50% yield*
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 39
Fixed cost leverage and automation drives gross margins
10MM** 60MM
Depreciation Overhead Labor Material
*Note: Illustrative. Based on internal estimates and subject to significant uncertainties.
**MM = Microarray volumes
Profitability and cost at various microarray sales levels*
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 40
Operating leverage drives profitability
10MM 60MM
COGS Operating Expenses EBIT
Revenue, costs
and EBIT in $
10MM** 60MM
*Note: Illustrative. Based on internal estimates and subject to significant uncertainties.
**MM = Microarray volumes
Takeaways
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 41
– Consistent strategy underpinned by
strong financial position
– Menu expansion progressing well
– Ready to launch
Q&A
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 42
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 43
QUOTIENT MANAGEMENTSpeaker bios
Franz Walt
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 44
Chief Executive Officer, Quotient
Franz Walt joined Quotient (NASDAQ:QTNT) as the company’s Chief
Executive Officer in March 2018. Quotient Limited is a commercial-
stage diagnostic company with an initial focus on blood grouping,
serological as well as molecular disease screening, based on its
proprietary MosaiQ™ technology platform.
Franz Walt brings 30 years of global experience in leadership roles at
two of the largest, most influential healthcare companies, Siemens
Healthineers and Roche, and as an expert advisor on the in-vitro
diagnostics industry to manufacturing companies and private equity
firms. His career has focused on business turnaround, above-market
growth, profitability improvement, innovation, strategic alliances,
quality, new product introduction and commercialization.
In December 2017, Mr Walt retired as President of Laboratory
Diagnostics for Siemens Healthineers. During his 23 years at Roche,
he held positions of increasing responsibility in pharma and
diagnostics, which includes CEO, Managing Director and President
roles, in various geographic regions for Roche Diagnostics, also
serving eight years as a member of the Roche Diagnostics Executive
Committee.
Mr Walt served as a board member of the AdvaMed DX industry
association, where he actively contributed to shape healthcare policy
in diagnostic testing to improve patient health. Mr Walt holds an MBA
from the City University of Bellevue (Washington).
Contact
D: +41 22 545 82 20
Quotient Suisse SA
Business Park Terre Bonne
Route de Crassier 13
1262 Eysins
Switzerland
Jeremy Stackawitz
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 45
President Commercial and Reagent, Quotient
Jeremy Stackawitz joined Quotient (NASDAQ:QTNT) 10 years ago,
overseeing the company through a period of sustained rapid growth.
He led Quotient’s entry into the US market, where the company
now serves over 1,000 customers and has successfully obtained over
60 FDA product approvals. He currently serves as President of
Commercial and the Reagent Business.
He brings over 20 years of experience in healthcare, including
diagnostics, pharmaceuticals and biotechnology. His past experiences
include serving in various business development, general
management and commercial roles for Johnson & Johnson, which
included Commercial Director of Immunohematology
for Ortho Clinical Diagnostics.
Previously he worked at Purdue Pharma running various Market
Research and Commercial groups, and served as a Strategy
Consultant to the healthcare industry with Monitor and McKinsey & Co
consultancies.
Mr Stackawitz holds a BA in Chemistry from Dartmouth College
and an MBA in Healthcare Management from The Wharton School,
University of Pennsylvania.
Contact
D: +1 215 497 8820
C: +1 215 432 9629
Quotient Suisse SA
Business Park Terre Bonne
Route de Crassier 13
1262 Eysins
Switzerland
Ed Farrell
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 46
President R&D and Manufacturing, Quotient
Edward Farrell joined Quotient (NASDAQ:QTNT) in February 2013
and serves as President of R&D and Manufacturing, overseeing
the product development and manufacturing of MosaiQ™ in
Switzerland and Scotland.
Mr Farrell has over 20 years of engineering, manufacturing and
R&D experience in medical diagnostics in various roles including
several senior positions.
While with Siemens Healthcare Diagnostics, Mr Farrell served
as Managing Director and Vice President with responsibility for R&D
and manufacturing, for a point-of-care diagnostic instruments and
consumables facility, and subsequently, for a high-volume
immunoassay reagent plant in the United Kingdom. Prior experiences
at Siemens include, working in the United States as Director for a
Distribution, Service and Repair site, and as a Senior Manufacturing
Manager in a large diagnostic instrument manufacturing plant in
Ireland. Previously Mr Farrell worked at Ingersoll Rand as a
Production Manager, as Intel Manufacturing Engineer and Supervisor.
Mr Farrell received a BE (Mechanical) and a Masters in Engineering
Science from University College Dublin.
Contact
D: +41 22 545 82 21
C: +44 7900 805487
Quotient Suisse SA
Business Park Terre Bonne
Route de Crassier 13
1262 Eysins
Switzerland
Chris Lindop
March 2019The MosaiQ™ system is not yet commercially available or approved by any government agency. 47
Chief Financial Officer, Quotient
Chris Lindop joined Quotient (NASDAQ:QTNT) as the company’s
Chief Financial Officer in February 2017.
Mr Lindop has more than 15 years of experience in senior finance
leadership roles with public healthcare companies. He previously
worked as Chief Financial Officer of Haemonetics Corporation
(NYSE:HAE), a global leader in blood processing technology and as
Chief Financial Officer of Inverness Medical Innovations, Inc., a global
developer, manufacturer and marketer of medical diagnostic products.
In addition, Mr Lindop was a non-executive director of Parexel
International Corporation (NASDAQ: PRXL) from 2006, where
he was chairman of the audit and finance committee and a member
of the nominating and governance committee until its sale.
Previously, he served as an audit partner with the Boston office
of Ernst & Young LLP and with the Boston office of Arthur Andersen
LLP. He holds a BA in Business from the University of Strathclyde
(Scotland).
Contact
D: +41 22 545 52 26
C: +41 79 961 69 38
Quotient Suisse SA
Business Park Terre Bonne
Route de Crassier 13
1262 Eysins
Switzerland