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© 2018 Curetis N.V.
CURETISADVANCING MOLECULAR MICROBIOLOGYTICKER SYMBOL: CURE (EURONEXT)
CORPORATE PRESENTATION
FEBRUARY 2018
DISCLAIMER & FORWARD LOOKING STATEMENTS
© 2018 Curetis N.V.2
This document has been issued by Curetis N.V. (the “Company” and, together with its subsidiary, the "Group") and does not constitute or form part of and
should not be construed as any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities of the Company,
nor shall any part of it nor the fact of its distribution form part of or be relied on in connection with any contract or investment decision, nor does it constitute a
recommendation regarding the securities of the Company or any present or future member of the Group.
In particular, this document is not an offer of securities for sale in the United States of America. Securities may not be offered or sold in the United States of
America absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Neither this document nor any copy of it
may be taken or transmitted into the United States of America, its territories or possessions or distributed, directly or indirectly, in the United States of
America, its territories or possessions or to any US person.
All information contained herein has been carefully prepared. However, no reliance may be placed for any purposes whatsoever on the information contained
in this document or on its completeness. No representation or warranty, express or implied, is given by or on behalf of the Company or any of its directors,
officers or employees or any other person as to the accuracy or completeness of the information or opinions contained in this document and no liability
whatsoever is accepted by the Company or any of its directors, officers or employees nor any other person for any loss howsoever arising, directly or
indirectly, from any use of such information or opinions or otherwise arising in connection therewith.
Where third-party information has been used in this document, the source of this information has been identified. The information in this document that has
been sourced from third parties has been accurately reproduced and, as far as the Company is aware and able to ascertain from the information published by
that third party, the reproduced information is correct. However, the Company has not verified the reproduced information and does not guarantee nor bear or
assume responsibility for the accuracy and completeness of the information from third-party sources presented in this document.
The information contained in this presentation is subject to amendment, revision and updating. Certain statements, beliefs and opinions in this document are
forward-looking, which reflect the Company’s or, as appropriate, senior management’s current expectations and projections about future events. By their
nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from
those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial
effects of the plans and events described herein. Statements contained in this document regarding past trends or activities should not be taken as a
representation that such trends or activities will continue in the future. The Company does not undertake any obligation to update or revise any information
contained in this presentation (including forward-looking statements), whether as a result of new information, future events or otherwise. You should not place
undue reliance on forward-looking statements, which speak only as of the date of this document.
By attending, reviewing or consulting the presentation to which this document relates or by accepting this document you will be taken to have represented,
warranted and undertaken that you have read and agree to comply with the contents of this notice.
CURETIS AT A GLANCE
© 2018 Curetis N.V.4
MULTIPLE PLATFORMS AND BROAD MDX PRODUCT OFFERING
Broad product portfolio & pipeline acceleration
From 5+ analyte triage-screen, via 10 to 30 marker rapid tests to 130 target syndromic panels
Publicly listed commercial stage MDx company Euronext Ticker Symbol CURE
Leadership in molecular microbiology
Unique antibiotic resistance marker capabilities helping to improve antibiotic stewardship
Covering several key technologies
High multi-(any)-plex PCR (endpoint and real-time), microarrays and NGS Bio IT solutions
Multiple platform options (Unyvero, A30 RQ, GEAR) with several marketed products
Curetis expects near-term U.S. FDA decision on De Novo request for Unyvero System and
LRT Cartridge
CURETIS AT A GLANCE
© 2018 Curetis N.V.5
MULTIPLE PLATFORMS AND GROWTH DRIVERS
Molecular Microbiology
Leadership
MOLECULAR
DIAGNOSTICS
AMR DATA
INTELLIGENCE
Any-plexSolution Content
Leadership
INVESTOR OVERVIEW
© 2018 Curetis N.V.6
KEY FACTS AT A GLANCE
Research Analyst Coverage
Analyst Institution Location
Kevin DeGeeter Ladenburg Thalmann New York City, U.S.
Nick Keher RBC London, U.K.
Chris Redhead goetzpartners London, U.K.
Stéphanie Put Degroof Petercam Brussels, Belgium
• Listed on Euronext Amsterdam and
Brussels
• Ticker symbol: CURE
• IPO: 11th Nov 2015
• No. shares outstanding: 15,538,411
• Raised Capital at IPO: € 44.3 M
19%
18%
9%8%
6%
13%
7%
20%
Curetis N.V. Shareholders
Calibrium ( ex aeris Capital)
LSP
Forbion
HBM
Roche
Others
Aviva
Free Float
RECENT NEWSFLOW
© 2018 Curetis N.V.7
CONTINUING TO EXECUTE
Initiated second U.S. FDA study for Unyvero Invasive Joint Infections (IJI) Application
Entered new collaboration and commercialization deals with MGI (a BGI company) to leverage
Curetis‘ proprietary Lysator sample preparation technology to enable the development and commer-
cialization of NGS Solutions for Molecular Microbiology
Company expects near-term U.S. FDA Deciscion on De Novo request for Unyvero System and
Unyvero LRT Cartridge
Signed Memorandum of Understanding with BGI for a broad collaboration to develop and
commercialize NGS Solutions for Molecular Microbiology
Signed Biotest pharma deal using Unyvero IAI Cartridge to test hundreds of clinical samples from
their phase IIb PEPPER trial
Grew installed base to 165 Unyvero Analyzers by 30 September 2017
© 2018 Curetis N.V.8
• Co-Founder Curetis
COMBINES DECADES OF OPERATIONAL AND COMMERCIAL EXPERIENCE
OUR MANAGEMENT BOARD
Dr. Achim Plum, CBO
~20 years in commercial
roles in IVD/MDx, Biotech &
Pharma
(ex Siemens, Epigenomics,
Schering)
Johannes Bacher, COO*
~20 years R&D and
management experience
(ex Hewlett Packard, Agilent
Technologies, Philips)
Oliver Schacht, Ph.D., CEO
~20 years in MDx
and biotech
(ex CFO Epigenomics AG
and CEO Epigenomics, Inc.)
© 2018 Curetis N.V.9
Christopher Bernard
CEO Curetis USA Inc. &
EVP Global Sales
Riwat Lim
Director Commercial Operations
EMEA
Dr. Helmut Hilbert
Head of Business Development
Dr. Andreas Posch
Managing Director Ares Genetics
GmbH, GEAR Bio-IT
Heiko Schorr
Director Finance
Bernd Bleile
General Counsel
Andreas Boos*
CTO and Managing Director
Curetis GmbH
Dr. Michael Schleichert
Director IVD Development
Dr. Gerd Luedke*
Director Innovation, Technology and IP*
• Co-Founder Curetis
COMBINES DECADES OF OPERATIONAL AND COMMERCIAL EXPERIENCE
DEEP MANAGEMENT TEAM
© 2018 Curetis N.V.10
William E. Rhodes, III
Chairman of the Board;
Chairman of Remuneration
Committee;
ex Becton Dickinson,
USA
Dr. Werner Schäfer
Vice chairman;
Chairman of Nomination &
Appointment Committee;
ex COO Roche Diagnostics,
Germany
Mario Crovetto
Chairman of the Audit Committee;
ex CFO Eurand / Recordati,
Italy
Dr. Nils Clausnitzer
Member of the BoardVWR International LLC / VWR GmbH
ex Qiagen, Olympus, Abbott
Germany
Prabhavathi Fernandes, Ph.D.
Member of the Board;
ex CEO of Cempra Pharmaceuticals Inc.,
Bristol-Myers Squibb Pharmaceutical
Research Institute, Abbott Laboratories,
USA
Dr. Rudy Dekeyser
Member of the Board;
LSP,
Belgium
Dr. Holger Reithinger
Member of the Board,
Forbion Capital Partners,
Germany
SUPERVISORY BOARD
EXPERIENCED AND DIVERSE NON-EXECUTIVE SUPERVISORY BOARD
© 2018 Curetis N.V.12
CLINICAL PRACTICE IS SLOW & INEFFECTIVE
MICROBIOLOGY SHORTCOMINGS> Takes 24-72+ hours, manual, labor-intensive
> Misses pathogens every 3rd to 4th sample
> Certain microorganisms hard to culture
> Multi-pathogen infections often challenging
> Often inadequate antibiotic therapy leading to
> increased length of stay in ICU
> higher mortality
> increased costs to hospitals
24-72+hours
~4 to 5 hours
UNYVERO IMPROVES UPON CURRENT STANDARD OF MICROBIOLOGY
~ 45 to
90 min
A30 RQ*
* in development, latest design concept;
final product may differ
© 2018 Curetis N.V.13
UNYVERO IN A NUTSHELL
FAST
COMPREHENSIVE
PANELS
FLEXIBLE ON SAMPLE
TYPES
EASY TO USE
CREATE HEALTH
ECONOMIC
BENEFITS
SUPPORT
ANTIBIOTIC
STEWARDSHIP
RAPID INFECTIOUS DISEASE TESTING FOR HOSPITALIZED PATIENTS
*
* in development, latest design concept; final product may differ
&
or
*
IMPROVE
CLINICAL
OUTCOMES
FOUR DISEASE-SPECIFIC CARTRIDGES WITH SYNDROMIC PANELS
BROAD CARTRIDGE MENU
14
Test can use any native
respiratory sample
Clinically validated in
thousands of patient samples
© 2018 Curetis N.V.
intra-
ROADMAP FOR MENU EXPANSION IN 2017 AND BEYOND
UNYVERO PRODUCT PORTFOLIO AND PIPELINE
15 © 2018 Curetis N.V.
**
**development completed; in clinical validation
*
*development completed; clinical evaluation to follow from 2018 onwards
© 2018 Curetis N.V.16
CURETIS‘ MARKET POTENTIAL
> 9.73M
cases
UNYVERO PORTFOLIO AND PIPELINE OF CARTRIDGES TARGET
OVER 9 MILLION PATIENTS ANNUALLY IN EU AND U.S.
2,329,000
2,128,215
393,810
1,976,130
1,312,700
1,600,000
Pneumonia (HPN/LRT)Implant and Tissue Infections (ITI)Blood Culture (BCU)Intra-Abdominal Infections (IAI)Sepsis Host Response (SHR)Urinary Tract Infections (UTI)
THE UNYVERO ADVANTAGE IN SYNDROMIC TESTING
© 2018 Curetis N.V.17
FOCUS ON MULTIPLEXING AND SAMPLE FLEXIBILITY R
ea
lize
d P
an
el S
ize
s
0
50
100
Screening
Syndromic
Testing
Proven Sample Type Flexibility
Low High
GenMark
ePlexBioFire
FilmArrayLuminex
(Nanosphere)
Verigene
T2Bio
T2DX
Cepheid
GeneXpert
Biocartis
Idylla
Curetis
Unyvero A50
Accelerate
PhenoTest™️ BC
Curetis
Unyvero A30 RQ*
* In development; targeted completion of development by end of 2018
CURETIS‘ BUSINESS MODEL
© 2018 Curetis N.V.18
INSTRUMENT PLACEMENTS AND CARTRIDGE UTILIZATION DRIVE SALES
TYPICAL SALES CYCLE 9 TO 12 MONTHS
Rasor / Rasor-Blade
Business Model> Systems placed free of charge in direct
sales markets
> ~€40k investment per installed system recouped by cartridge sales over time
> Cartridges purchased at or near list price / reagent-rental Unyvero
> Customers using between 200-600 cartridges per year
> Customers now running both P55 and i60
> 1-2 cartridges/day translate to €50-100k per year
> Recurring cartridge sales target gross margins of 70%+
Finance & Admin
- Improved health
economics
- Increased margins on
DRGs
Benefits
for Key Stakeholdersin hospitals
Microbiology Lab
- 24h / 7 day operation
- Minimal hands-on-time
ICU / Clinicians
- Fast actionable
information
- Point of need
- Antibiotic stewardship
Razor / Razor-Blade
Business Model
> Systems placed under reagent-rental / rent-to-own in direct sales markets
> ~ EUR 40,000 investment per installed system recouped by cartridge sales over time
> Target customers using between 200-600 cartridges per year
> Customers running menu of cartridges over time
> 1-2 cartridges/day translate to approx. EUR 30,000-75,000 recurring revenue potential per customer year
DUAL COMMERCIAL STRATEGY
© 2018 Curetis N.V.19
COMBINATION OF DIRECT SALES & DISTRIBUTORS
EUROPE U.S. ROW
Direct Sales & Marketing
Indirect Sales & Marketing via Distributors
Germany
Italy SpainPortugal
Romania Bulgaria
Russia Thailand Ukraine Qatar
MalaysiaSingapore
Kuwait Belarus
Indonesia
France
Netherlands Luxembourg
United
KingdomUnited States*
Belgium
*planned future direct sales, **recently signed distribution deals
China
Hong Kong
Taiwan
Austria
Czech
Republic
Slovenia
Slovakia
Croatia
Switzerland
Greece
**
Israel
**
Kazakhstan
UAE
BALANCED MANUFACTURING SET-UP
20
CARTRIDGE MANUFACTURING IN HOUSE – INSTRUMENTS OEM
> Operational capacity of up to 1 million cartridges (24/7 processing) annually
> Seamless supply chain management
Cartridges
> Experienced manufacturing and QC teams (ex Abbott, Philips)
> ISO 13485 certified
> Dedicated 1,600 m² facility for cartridge manufacturing Two ISO-8 and one ISO-7 clean-rooms Three QC laboratories Scalable capacity
Instruments
> Unyvero Systems manufactured by Zollner Elektronik (Top-tier EMS Provider)
Logistics
> Logistics by Hegele and TNT
> Hundreds of shipments in last 12 months
© 2018 Curetis N.V.
© 2018 Curetis N.V.22
USA
> Curetis expects near-term U.S. FDA decision
on De Novo request for the Unyvero System
and Unyvero LRT Application
> Final review of labeling under way
> Multi-center trial at 9 sites, total of 2,202
patient samples, over 350,000 data points,
91.4% sensitivity and 99.5% specificity*
> Started collection of patient samples for
second FDA trial - Unyvero IJI (invasive joint
infections) Cartridge, prospective clinical trial
expected to start in 2018
> Progressed preparations for future
submission of BAL sample types
China
> Good progress in analytical testing in China – expect clinical trial enrolment to start in due course
> CFDA trial to be carried out by our partner BCB with completion not expected before end of 2018
with commercial impact expected from 2019 onwards.
GEOGRAPHIC EXPANSION: USA & CHINA
NEAR-TERM U.S. FDA DECISION ON DE NOVO REQUEST FOR THE
UNYVERO SYSTEM AND LRT APPLICATION USING ASPIRATES EXPECTED
* weighted average across all panel analytes
© 2018 Curetis N.V.23
> Headquarters of Curetis USA, Inc. in San Diego, CA
> Senior U.S. executive leadership team on board with track record in diagnostics (ex Cytyc,
Abaxis, Genmark) plus initial hires in operations, clinical application and field service support and
recent hiring of experienced key regional sales and commercial support positions
> Preparations for launch upon clearance well underway
> Recruiting campaign in progress for additional hires in sales, application specialists, field service –
target on-boarding just ahead of expected FDA clearance decision
> Guided towards 25 to 40 Unyvero Analyzer placements within 6 to 9 months of full commercial
U.S. launch – installations under IUO label in Q3/Q4 - warehouse stocked ahead of launch
GEOGRAPHIC EXPANSION: CURETIS USA, INC.
GETTING READY TO ENTER THE WORLD’S LARGEST MDx MARKET
© 2018 Curetis N.V.25
A30 RQ Key Features
> Low- to Midplex with 5-30 targets
> Sensitive and quantitative real-time PCR
technology
> Processes any native samples
leveraging Unyvero Lysator when required
> Rapid 45-90 min time-to-result
> Easy to use with 2-5 min hands-on-time
> Small foot-print
> Point-of-care capable
> Low COGS Target: >66% reduction vs.
current high-plex Unyvero (Instrument &
Consumables)
> Modular concept for full integration with
other Unyvero modules or stand-alone
operation
EXPANSION TO LOW- AND MID-PLEX APPLICATIONS
UNYVERO A30 RQ: SMALL, FAST, QUANTITATIVE
A30 RQA new midplex
analyzer module for
Unyvero 2.0
integration
or standalone
operation
A30 RQ*
Unyvero 2.0 Concept*
* latest design concept; final product may differ
© 2018 Curetis N.V.26
Current Development Status
> Industrial designs available; working with external development partners and design firm
> Integration with Lysator possible (but not required), using identical Unyvero Sample Tube
> Design-freeze expected for Q1/2018
TARGET COMPLETION OF DEVELOPMENT BY END OF 2018
UNYVERO A30 RQ: R&D PROGRESSING AS PLANNED
SampleTube
LiquidHandlingWheel
PCRWheel
Waste
Reaction/MixingChambers
Reagents
Reagents
ca
. 1
6 inch
A30 RQ*
* latest design concept; final product may differ
27
> Expected to drive development of A30 RQ Analyzer module towards completion by end of 2018
and with commercial launch expected in 2019
> Leveraging synergies with R&D, (OEM) manufacturing and supply chain, clinical operations,
quality management & regulatory affairs and commercial infrastructure already established
> Accelerating product pipeline
> Expect content to be synergistic with expanding Unyvero portfolio and sales channel e.g. in the
areas of sepsis, respiratory infections and antibiotic resistance
> Significant upside from third party partnering opportunities with potential fast-track program and
possible co-funding by IVD companies and pharma CDx
Unyvero A30 RQ
low- to midplex
Unyvero A50
mid- to highplex
© 2018 Curetis N.V.
UNYVERO 2.0
EXPANDING TO ANY-PLEX SOLUTION
> EMEA launch of new Intra-Abdominal Infection (IAI) Cartridge during ECCMID 2017
> Development of Urinary Tract Infections (UTI) Cartridge completed; now in clinical
validation
> Development of Sepsis Host Response (SHR) Cartridge completed in 2017; to be tested
with IUO labeling for clinical evaluation from 2018 onwards.
> Adding further differentiated Unyvero Cartridges to the pipeline with next cartridges
> Continuous life cycle management of selected key applications
> Novel applications on A30 RQ adding to portfolio from 2019 onwards28 © 2018 Curetis N.V.
UNYVERO ANALYZER A30 RQSYNERGISTIC ASSAY PIPELINES TOWARD AN ANY-PLEX PORTFOLIO
Menu Expansion on A30 RQThe Unyvero Portfolio Menu Expansion on A30 RQ
**
**development completed, in clinical validation*development completed
*
GEAR
> Most comprehensive database on
genetics of antibiotic resistance
> Acquired asset from Siemens in Q3/2016
> Growing data set of 1,000s of clinical
isolates NGS sequenced and profiled on
most relevant antibiotics
> Fueling core business with biomarkers
> Upside in database products, clinical
decision support, pharma services and
licensing
Content for Unyvero RQ
Database Products & Decision Support Tools
Pharma Services
© 2018 Curetis N.V.
GEARing UP FOR INNOVATION
BASIS FOR COLLABORATIVE RESEARCH & CONTENT LEADERSHIP
26
GEAR Status
> Established Ares Genetics GmbH in
Vienna as wholly owned Curetis Group
company
> Hired Dr. Andreas Posch as Director
GEAR Bio-IT and GM for Ares Genetics
from Siemens
> Completed Ares core team
> Signed MGI/BGI partnership MoU
> Won first AT grant project
> Applied for further GEAR-related grants
> Won Innovation Prize
> Submit for further non-dilutive grant funding internationally
> Open up GEAR for innovative partnering opportunities with IVD and NGS companies and pharma
with potential upside from additional deal-making activities in the coming quarters
30 © 2018 Curetis N.V.
GEARing UP FOR INNOVATION
BASIS FOR COLLABORATIVE RESEARCH & CONTENT LEADERSHIP
31 © 2018 Curetis N.V.
MEDICAL ADVISORY BOARDEXPERTS FROM THE FIELD ADVISING CURETIS
Dr. Reno Frei
formerly Head of the Division of Clinical
Microbiology, University Hospital Basel,
Switzerland
Prof. Robin Patel, MD
Chair of the Division of Clinical
Microbiology, Mayo Clinic,
USA
Prof. Mathias Pletz
Director of the Center for Infectious
Diseases and Infection Control at the
Jena University Hospital,
Germany
Prof. Jean-Louis Vincent, MD, Ph.D.
Department of Intensive Care,
Erasme University Hospital, Brussels,
Belgium
Dr. Laurent Poirel
Associate Professor of Microbiology,
University of Fribourg,
Switzerland
Dr. Melissa Miller, Ph.D., D(ABMM)
Professor of Pathology and Laboratory
Medicine at the University of North
Carolina at Chapel Hill School of Medicine,
USA
BUILDING A MOLECULAR MICROBIOLOGY LEADER
© 2018 Curetis N.V.32
EXPANDING UNYVERO BY BUILDING A DATA-DRIVEN NEXT GENERATION
MOLECULAR MICROBIOLOGY FRANCHISE
WHY INVEST IN CURETIS?
© 2018 Curetis N.V.33
LEADER IN MOLECULAR MICROBIOLOGY WITH MULTIPLE
PLATFORMS, PRODUCTS AND DIFFERENTIATED CONTENT
> U.S. FDA near-term decision on De
Novo request expected by Curetis
> U.S. launch upon FDA’s granting of
De Novo request
> Unyvero Analyzer A30 RQ and GEAR
growth drivers
> Commercial stage in EMEA
> Asian partners to fuel future growth
> Broad pipeline driving menu expansion
> Validated by KOLs
> Well funded
> Strategic partnering upside
> Experienced team driving execution
© 2018 Curetis N.V.34
Curetis N.V.
Max-Eyth-Str. 42
71088 Holzgerlingen | Germany
Tel.:+49 (0)7031/49195-10
E-Mail: [email protected]
www.curetis.com