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transcript
MosaiQ™ by Quotient
Jefferies Healthcare Conference, London
November 14, 2018
Transfusion diagnostics and beyond
Chris Lindop, Chief Financial Officer
Safe Harbor Statement
This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E ofthe Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements includestatements regarding our expectations of continued growth, the development, regulatory approval, commercialization, and impact ofMosaiQ and other new products (including our current expectations regarding the timing of MosaiQ project milestones) and forecasts of thedemand for MosaiQ Microarrays and our expected sources of funding. Such statements are based on current assumptions that involve risksand 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 forproducts or applications; market acceptance of our products; the impact of competition; the impact of facility expansions and expandedproduct development, clinical, sales and marketing activities on operating expenses; delays or other unforeseen problems with respect tomanufacturing, 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 thecompany's filings with the Securities and Exchange Commission (“SEC”). Investors are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date hereof. Quotient disclaims any obligation to update these forward-lookingstatements.
The Quotient logo and MosaiQ are registered trademarks or trademarks of Quotient Limited and its subsidiaries in various jurisdictions. Anyimages, schematics or other graphic or pictorial representations contained herein, including those representing the MosaiQ™ Instrument orMicroarrays, are for illustrative purposes only. Those representations may change and may not accurately represent final Quotient productsor services.
This presentation contains statistics and other data that in some cases have been obtained or compiled from information made available bythird parties. Quotient makes no representation or warranty, expressed or implied, with respect to the accuracy, reasonableness orcompleteness of such information.
November 14, 2018 The MosaiQ system is not yet commercially available or approved by any government agency 2
Quotient: an established manufacturer of transfusion diagnostics
Eysins, Switzerland Global headquarters and MosaiQ microarray manufacturing
Edinburgh, United Kingdom Reagent business and MosaiQ product development
Newtown – Pennsylvania, USA US Commercial base
History 2018 – 72 reagents products CE marked and 63 FDA licensed
2014 – Quotient Suisse SA formed and Quotient IPO on Nasdaq
2007 – Quotient founded and acquired Alba Bioscience
1998 – Diagnostics Scotland (later renamed Alba Bioscience) created from merger of NRU and Scottish Antibody Production Unit
1990 – Scottish National Blood Services creates National Reagents Unit
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Innovating for transfusion laboratories for over 30 years
November 14, 2018
Transfusion diagnostics testingNeeds three different testing modalities on the donor side
Serological Disease Screening
Blood GroupingIncl. Extended Antigen Typing
Molecular Disease Screening
4November 14, 2018
Blood transfusionA long and complex value chain
Donor goes to blood collection centre
Blood donationcollected
Blood samples sent to lab for testing
Suitable blood unitsstored at blood bank
Blood units deliveredto hospital
Hospital checks blood compatibility for patient
Patient transfused with suitable units
5November 14, 2018
Transfusion diagnostics market overviewGlobal market value of $3.4 billion*
Donor Testing2/3
Patient Testing1/3
IH
$325mSDS
$875mMDS
$1,100mIH
$1,100m
Concentrated marketUS customers: 2 playersEuropean customers: 2-25 per countryTest volume: high
Fragmented marketUS customers: most hospitalsEurope customers: most hospitalsTest volume: low
* Source: BCC Research, The Global Blood Industry, March 2015
6November 14, 2018
Potential for increasing efficiency in the labDonor testing today requires multiple platforms, modalities and techniques
Expanded IH & initial SDS
Blood grouping
SDS (CMV & Syphilis)
Blood grouping only Manual Testing
SDS
MDS
MDS
Expanded SDS
7November 14, 2018
Transfusion diagnostics marketFragmented market with many high specialized players
Sources: LEK, 2016; and Quotient
IH
SDS
MDS
8November 14, 2018
Transfusion diagnostics marketMosaiQ has the potential to cover all three types of diagnostic testing with one single technology
Sources: LEK, 2016; and Quotient
IH
SDS
MDS
November 14, 2018 9
Experts’ points of viewExperienced leaders in testing labs share the issues they see
Prof M SchmidtHead of Blood Donor ScreeningGerman Red CrossBaden-Württemberg, Hesse
Mr B BlockPresident & CEOBlood Centers of America
Dr P WilliamsonVice PresidentOperations & Scientific AffairsCreative Testing Solutions
Multiple instruments
Different instruments needed, adding complexity and taking up space
Need to increase walk-away time
Dr E CastroHead of Donor TypingBlood Donor Center, Valencia
Lack of innovation
Sector ripe for innovation
Techniques & technologies not evolved
Inefficient workflow
Many steps not automated, requiring human intervention
Extensive use of manual testing
Shortage of trained technicians
More demands & complexity
More demands due to ageing population
No compromise on safety or quality
10November 14, 2018
Quotient has listened to the market and its customersMosaiQ has been designed to provide needed solutions and outcomes
One technology
Comprehensive IH characterization
Serological disease screening
Molecular disease screening
Better resource management
Reduced sample volumes
Longer reagent shelf life
Fewer sample tubes
Improved workflow
Fully automatic process
Reduced testing time
Reduced manual testing
Increasing lab efficiency and improving clinical practice
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Creating value for customers, shareholders and QuotientMoving to a new paradigm: Focusing on total cost per donation
Direct & associated testing costs
Non-direct costs
Cost-saving potential
Non-direct costs
Associated testing costs
Direct testing costs
Current practice Quotient
12November 14, 2018
The MosaiQ microarray
Innovative microarray-enabled approach to transfusion diagnostics
Over $300m invested since 2012
Manufacturing capability completed
Automated testing platform completed
Initial IH microarray EU field trials successfully completed and submitted for CE marking
Low-cost multiplex solution is adaptable to multiple menus and testing methods
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The MosaiQ all-in-one systemPioneering, patented and proprietary technology platform
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MosaiQ EU Field Trial: Concordance data for initial IH Menu
A B D C c E e Cw K k
Concordance 99.9% 99.4% 99.5% 99.9% 99.6% 100.0% 99.9% 100.0% 99.9% 100.0%
Greater than 3,000 donations tested in the concordance portion of field trial
Blood Group Antigen – Required to be 99% concordant with the predicate
The above results imply overall concordance of 99.8% for the MosaiQ antigen typing microarray
Antibody Detection
Concordance 97.5%
Antibody Detection – Required to be 95% concordant with the predicate
Source: Quotient media release, “Quotient Limited reports the submission of the initial IH CE mark filing and the successful completion of the key regulatory audits of its new BioCampus facility” - 25 September 2018
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Development overviewThree major technology development projects in parallel
Manufacturing
Instrument
Microarray
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ISO 13485 audit completed without findings
MosaiQ DeviceCE Marked
CE mark submission in late September 2018
Go-to-market: Regulatory and commercial milestonesOutlook of current and upcoming menu expansion
ExpandedMosaiQ™ SDS Microarray
Expanded MosaiQ™ IH Microarray
Initial MosaiQ™ IH Microarray
InitialMosaiQ™ SDS Microarray
MosaiQ™ MDS Microarray
Potential screening panels e.g. allergies, women’s health, etc
CY2018 CY2019EU EU
EU
US US & EU
EU US
Development to field trials
Feasibility to early development
Feasibility
DevelopmentInvitation to tender on approvalPlanning
SubmissionField Trials
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The addressable market could expand to other diagnostic areasPotential global transfusion market and beyond
SDS MDS
Donor Testing
IH
Other Screening Applications
Allergies Women’s health
Other panels
Patient Testing
IH
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Takeaways
30-year heritage and expertise in the development and commercialisation of transfusion diagnostics
Significant investment, development progress and de-risking of MosaiQtechnology
Technology applicable in transfusion diagnostics and beyond
19November 14, 2018 The MosaiQ system is not yet commercially available or approved by any government agency
MosaiQ™ by Quotient
Jefferies Healthcare Conference, London
November 14, 2018
Transfusion diagnostics and beyond
Chris Lindop, Chief Financial Officer
Chris Lindop – Chief Financial Officer - Quotient
21November 14, 2018 The MosaiQ system is not yet commercially available or approved by any government agency
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: chris.lindop@quotientbd.com – D: +41 22 545 52 26 / M: + 41 79 961 69 38
Quotient Suisse SA - Business Park Terre Bonne – Route de Crassier 13 – 1262 Eysins – Switzerland
MosaiQ™ by Quotient
Jefferies Healthcare Conference, London
November 14, 2018
Transfusion diagnostics and beyond
Chris Lindop, Chief Financial Officer