CURETIS ADVANCING MOLECULAR … ADVANCING MOLECULAR MICROBIOLOGY TICKER SYMBOL: CURE (EURONEXT)...

© 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.

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nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from

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CURETIS: INTRODUCTION

CURETIS AT A GLANCE


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


MULTIPLE PLATFORMS AND GROWTH DRIVERS

Molecular Microbiology

Leadership

MOLECULAR

DIAGNOSTICS

AMR DATA

INTELLIGENCE

Any-plexSolution Content

Leadership

INVESTOR OVERVIEW


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


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


• 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.)


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


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


UNYVERO: CURETIS’ SOLUTION FOR MOLECULAR

MICROBIOLOGY


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


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


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


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


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


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


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



OUTLOOK: GEOGRAPHIC EXPANSION


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


> 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


OUTLOOK: PRODUCT PORTFOLIO DEVELOPMENT

24


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


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


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


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


GEARing UP FOR INNOVATION

BASIS FOR COLLABORATIVE RESEARCH & CONTENT LEADERSHIP


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


EXPANDING UNYVERO BY BUILDING A DATA-DRIVEN NEXT GENERATION

MOLECULAR MICROBIOLOGY FRANCHISE

WHY INVEST IN CURETIS?


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


Curetis N.V.

Max-Eyth-Str. 42

71088 Holzgerlingen | Germany

Tel.:+49 (0)7031/49195-10

E-Mail: [email protected]

www.curetis.com

CURETIS ADVANCING MOLECULAR … ADVANCING MOLECULAR MICROBIOLOGY TICKER SYMBOL: CURE (EURONEXT)...

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