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Biocartis Corporate Presentation March 2017

Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

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Page 1: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Biocartis Corporate Presentation March 2017

Page 2: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

NOTICES AND WARNINGS

This presentation has been prepared by the management of Biocartis Group NV (the "Company"). It does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, underwrite or otherwise acquire, any securities of the Company or any member of its group nor should it or any part of it form the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of the Company or any member of its group, nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. It is not a prospectus or offering memorandum. The information included in this presentation has been provided to you solely for your information and background and is subject to updating, completion, revision and amendment and such information may change materially. No person is under any obligation to update or keep current the information contained in this presentation and any opinions expressed in relation thereto are subject to change without notice. No representation or warranty, express or implied, is made as to the fairness, accuracy, reasonableness or completeness of the information contained herein. Neither the Company nor any other person accepts any liability for any loss howsoever arising, directly or indirectly, from this presentation or its contents. This presentation includes forward-looking statements that reflect the Company's intentions, beliefs or current expectations concerning, among other things, the Company's results, condition, performance, prospects, growth, strategies and the industry in which the Company operates. These forward-looking statements are subject to risks, uncertainties and assumptions and other factors that could cause the Company's actual results, condition, performance, prospects, growth or opportunities, as well as those of the markets it serves or intends to serve, to differ materially from those expressed in, or suggested by, these forward-looking statements. The Company cautions you that forward-looking statements are not guarantees of future performance and that its actual results and condition and the development of the industry in which the Company operates may differ materially from those made in or suggested by the forward-looking statements contained in this presentation. In addition, even if the Company's results, condition, and growth and the development of the industry in which the Company operates are consistent with the forward-looking statements contained in this presentation, those results or developments may not be indicative of results or developments in future periods. The Company and each of its directors, officers and employees expressly disclaim any obligation or undertaking to review, update or release any update of or revisions to any forward-looking statements in this presentation or any change in the Company's expectations or any change in events, conditions or circumstances on which these forward-looking statements are based, except as required by applicable law or regulation. This document and any materials distributed in connection with this document are not directed to, or intended for distribution to or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction. The distribution of this document in certain jurisdictions may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe any such restrictions. The Company's securities have not been and will not be registered under the US Securities Act of 1933 (the "Securities Act") and may not be offered or sold in the United States absent registration under the Securities Act or exemption from the registration requirement thereof.

2

Page 3: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

High precision diagnostics for high precision medicine

• ‘First time right’ molecular diagnostic system

• Combining advantages of point of care testing

with quality of lab reference testing

EARLY DIAGNOSIS

• Rapid diagnosis • High sensitivity • Comprehensive panels

THERAPY SELECTION

• Treatment guidance • Companion diagnostics

PATIENT MONITORING

• Monitoring of treatment progress

• Early detection of relapse Idylla™

3

Page 4: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Idylla™ best-in-class

• Accurate results at right sensitivity

• Fully automated sample-to-result

• Any clinical sample type

• High levels of multiplexing

• Short turnaround time

• Modular and scalable

• Data connectivity

Inst

rum

ent

Conso

le

Disposable cartridge 4

Page 5: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Limitation of erroneous results due to standardized

cartridge

• Any sample type

• No sample pre-treatment

• All reagents on board

• No PCR lab infrastructure

• No cold chain

• Stable at room temperature

Offering potential for CLIA waiver

5

Page 6: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Excellent performance in comparative studies

6

Overview 2016 comparative studies* Key takeaways

• Superior sensitivity compared to competing NGS and qPCR technologies

• Unrivalled ease of use

• Shorter turnaround times

• Flexibility towards different sample types

• Suitable for both solid and liquid biopsies

2x BRAF

1x NRAS

3x KRAS

2x EGFR

By t

est

By c

hannel

3x

1x

1x

1x

* Janku et al. BRAF Mutation Testing in Cell-Free DNA from the Plasma of Patients with Advanced Cancers Using a Rapid, Automated Molecular Diagnostics System. Mol Cancer Ther (2016) 15(6): 1–8; Schreuer et al. Quantitative assessment of BRAF V600 mutant cell-free tumor DNA from plasma as a diagnostic and therapeutic biomarker in patients with BRAF V600 mutant melanoma. ASCO 2015; De Biase et al. ‘Fully Automated PCR detection of KRAS Mutations on Pancreatic Endoscopic Ultrasound Fine Needle Aspirates’. J Clin Pathol 2016; Reijans et al. ESMO 2016, published on 6 October 2016; De Luca et al., J Clin Pathol 2016; J.L. Sherwood et al., KRAS – ESMO Abstract 91 P: “Implications of key differences across 12 KRAS mutation detection technologies and their relevance in clinical practice”; Ellen Vercauteren et al., NRAS – ESMO Abstract 1175P: “Ultra-rapid, sensitive, and fully automated extended RAS testing for metastatic colorectal cancer – evaluation of an NRAS/BRAF/EGFR492 module”; Preliminary Performance Study based on Research data. Martin Reijans et al., EGFR – ESMO Abstract 1173P: “Fully automated and sensitive detection of EGFR exon 18, 19, 20 and 21 mutational status in less than 2.5 hours from a single FFPE slice”; Jérôme Solassol et al., “Multi-Center Evaluation of the Fully Automated PCR-Based Idylla™ KRAS Mutation Assay for Rapid KRAS Mutation Status Determination on Formalin-Fixed Paraffin-Embedded Tissue of Human Colorectal Cancer”

Page 7: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

AstraZeneca study confirms best-in-class status Idylla™

Background

Source: poster by James L. Sherwood et al., presented at 2016 ESMO conference Copenhagen (Denmark)

Conclusions

7

• Comparative study organized by AstraZeneca

• Comparison of 12 different KRAS mutation detecting technologies:

• Focused on detection of KRAS mutations in lung cancer based on blinded samples

5x NGS

3x qPCR

2x mass spec.

1x ddPCR

1x Sanger sequencing

Sensi

tivity

Technology Overall sensivity

Idylla™ KRAS 96%

Other qPCR (cobas/therascreen) 46-52%

Mass-spectrometry 58-92%

NGS 48-100%

ddPCR 56%

Sanger sequencing 0%

Ease

-of-

use

TaT**

• Highest score for Idylla™ KRAS technology: o Lowest number of manual handling steps in sample

preparation (1 to 2 steps versus 3 to > 20 steps) o Requires lowest level of expertise (1 versus 2-4 for

others*)

* One being the lowest level of expertise and four the highest ** TaT = total turnaround time

• Highest score for Idylla™ KRAS technology on total turnaround time (2 to 4 hours versus 1 day to 3 weeks)

Page 8: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Rapidly expanding test menu

8

Page 9: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Menu for oncology and infectious diseases

1. Source: Markets & Markets: In Vitro Diagnostics (IVD) Market by Product Technology by Application - Forecast to 2021 2. FFPE is abbreviation of Formalin-Fixed Paraffin Embedded

Oncology – primary focus Infectious diseases

Fastest growing segment of the MDx market1 - CAGR of 17% between 2016-2021

Largest segment of the MDx market1 – 43% of total in 2016

• FFPE*-based sample to result solutions

• Solid and liquid biopsy testing on same platform

• Reduction of time to result from weeks to hours

• Proprietary assay content within immuno-oncology

• Gateway to Next-Generation Sequencing

• Ability to offer syndromic panels that include quantitation, RNA and DNA combinations

• Short turn around times combined with ease of use and high sensitivity

• Broad sample type and volume capabilities

• Sample enrichment technology for sepsis and other bloodstream infections

• Solid biopsies and liquid biopsies

• Clinically proven and reimbursed biomarkers

• Proprietary content in second wave

• Syndromic panels

• Bloodstream infections (including sepsis)

• Infectious disease strategy going forward could include more partnership elements

USPs

Focu

s

(Focus on CDx development)

9

(Strategic partnership)

(Focus on mCRC)

(Diagnostic test development partnerships)

Menu partners

Page 10: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Our Idylla™ menu

10

Onco Solid Biopsy

Onco Liquid Biopsy

Infectious

IdyllaTM Retrieve

On market end 2016 2017 2018 Focus as from 2019 (indicative) Area

Melanoma

Colorectal

Lung

Other

Infectious diseases

KRAS CE

NRAS-BRAF CE

NRAS/BRAF/EGFR492 RUO

ctKRAS RUO

ctNRAS/BRAF/ EGFR492 RUO

NRAS CE

ctKRAS CE

ctNRAS-BRAF CE

MSI

EGFR RUO EGFR CE

ctEGFR RUO

ctEGFR CE

BRAF CE

ctBRAF RUO

MSI (immunotherapy)

NGS Hotspot Panel

Onco

logy

IFV-RSV Panel CE+

Ebola EUA

Syndromic panels (initial assay Respiratory MP++) and bloodstream infections (including sepsis)

CDx CDx

signed Additional CDx programs to be added

CDx

GeneFusion Panel

Colorectal

• Additional assays to be launched for CRC and lung cancer menus

• Expansion into major oncology areas: o Breast o Urology o Immunotherapy o DNA repair*

• Additional NGS Prep Panels to be launched for number of pan-tumor indications

CE = CE-marked tests. RUO = Research Use Only. EUA = Emergency Use Authorization label + JnJ test ++ Fast-track Diagnostics development

Note: overview is subject to changes in prioritization of test development driven by several factors such as commercial and operational considerations. Overview excludes regional expansion, life cycle management and potential partner tests.

IFV-RSV Panel 510k+

On market assay

Page 11: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Menu expansion 2016 focused on mCRC and lung cancer

11

KRAS Solid RUO Solid CE Liquid RUO Liquid CE

mCRC

Lung c

ance

r

NRAS-BRAF Solid RUO*

Solid CE Liquid RUO* Liquid CE

EGFR Solid RUO Solid CE Liquid RUO Liquid CE

BRAF Solid RUO Solid CE Liquid RUO Liquid CE

Mela

nom

a

* The panel composition of these assays will also include the EGFR492 mutation

CE = CE-marked tests. RUO = Research Use Only, not for diagnostic procedures. Depicted products are not for sale in the USA and Canada. ** Development of a CE-marked ctBRAF test subject to inclusion in clinical guidelines and/or client demand

• Completion of mCRC test offering for clinical use with CE-marking Idylla™ NRAS-BRAF Mutation Test: o Follows most recent clinical

guidelines o Opens routes towards faster

treatment selection

• First assay under Merck KGaA collaboration launched: Idylla™ ctKRAS Assay

• Launch first test lung cancer menu with Idylla™ EGFR Mutation Assay RUO: important addition to core menu

**

Page 12: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Continued expansion global commercial footprint*

Over 60 countries covered through three sale channels:

Direct sales force covering Western European countries

Distributor contracts in place covering approx. 45 countries

• US commercialization partnership signed in November 2016

• Announcement commercialization strategy China in 2017

• Announcement commercialization strategy Japan in 2017/2018

Global pharma collaborations (e.g. Merck and Amgen)

1

2

3

* Situation as per 31 December 2016 12

2017

2017/2018

Direct – reps on the ground

Distributors – signed up

Partnership under discussion

Page 13: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

US commercialization partnership with Thermo Fisher

13

Description partnership Background Thermo Fisher Scientific3

• Partnership signed with Fisher Healthcare, a division of

Thermo Fisher Scientific

• Thermo Fisher to act as distributor in the US1 Biocartis retains

right to sell directly

• Initial focus on distribution of Idylla™ oncology products

• 5 year initial term

• Biocartis to establish a US subsidiary and local team to support

US commercialization in H1 2017 - commercial roll-out

expected in H2 2017

• World leader in serving science

• Annual revenues of approx. $17 billion

• Approximately 50,000 employees in 50

countries

• Experienced nationwide sales team in place

1 Exclusive for Biocartis’ Idylla™ assays; non-exclusive for Idylla™ instruments 2 MarketsandMarkets, Molecular Diagnostics Market - Forecast To 2020 3 http://www.thermofisher.com/be/en/home.html

US expected to account for the largest proportion of the MDx market for oncology (expected market size of $1.45B by 2020) and infectious disease (expected market size of $1.07B by 2020)2

Page 14: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Growing interest from pharmaceutical and biotech companies

14

• Collaboration aimed at improving patient access to ctRAS testing by leveraging the advantages of Idylla™

• Development of CE-IVD Idylla™ liquid biopsy tests for KRAS and NRAS/BRAF tests

• Subsequent implementation of tests in numerous medical centers across the world3

• Collaboration aimed to offer Idylla™ RAS testing for rapid decentralized testing

• Initiated in February 2016 with sites in 7 countries2

• Significantly expanded in Europe end of 2016 adding several dozen sites

1. Amgen data 2. Focused on selected reference hospitals in Brazil, Canada, Colombia, Mexico, Saudi Arabia, Spain and Turkey. 3. US, China and Japan are excluded from this collaboration. Commercialisation of assays under the collaboration is on a non-exclusive basis.

Rationale

• Timely information on presence of mutations is critical in treatment selection; testing needed for patients to be eligible for targeted therapies

• In case of mCRC, testing of RAS genes is required for anti-EGFR therapies (e.g. Vectibix® of Amgen and Erbitux® of Merck)

• Technologies currently used are complex and often require several weeks1

• This could result in situations where patients are not in the position to benefit from targeted therapies as oncologists often don’t want to wait before initiating a treatment

Current collaborations

Page 15: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

2016 results and 2017 Outlook

15

Page 16: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Key messages 2016 results

Installed base Idylla™ instruments more than doubled in 2016 by adding a total of 224 instruments

Total installed base year end was close to 390 instruments.

Revenues

Cash position

Installed base

16

Cartridge consumption

Commercial cartridge volume in 2016 increased to over 25,000 cartridges which represents approx. 7.5 times the total commercial volume of 2015.

Menu On market oncology menu expanded to 7 tests

Product revenues in 2016 amounted to EUR 6.8m, representing an increase of 88% compared to 2015

Total 2016 operating income amounted to EUR 13.8m

Cash and cash equivalents on 31 December 2016 amounted to EUR 83.2m

Page 17: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Idylla™ follows a razor-razorblade model

• Cartridge consumption on Idylla™ instruments will be the key value driver of Biocartis

• A broad installed base of Idylla™ instruments with expanding Idylla™ test menu facilitates cartridge consumption

An increasing installed base will: • Grow consumption of existing Idylla™ tests • Accelerate market adoption of new Idylla™ tests

Instrument installed base growth

Test

menu e

xpansi

on

17

Page 18: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

18

Idylla™ installed base more than doubled to 389

82

389

83

165

224

2014 Increase2015

31-Dec-15 Increase2016

31-Dec-16

Installed base development

• Continued menu expansion: o Completion CE-marked offering for metastatic colorectal

cancer (mCRC) o Launch of lung cancer menu with Idylla™ EGFR

Mutation Assay

• Growing interest from pharmaceutical and biotech companies

• Increased awareness by end customers on excellent performance Idylla™ technology as shown in recent performance studies

* The Idylla™ EGFR Mutation Assay is intended for Research Use Only, not for diagnostic procedures. Not for sale in the USA and Canada.

2016 growth drivers

1

2

3

Page 19: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

19

Exponential increase of cartridge volume in 2016

2015 end of the year 2016 end of the year

Installed base 165

Idylla™ tests 5

Installed base 389

Idylla™ tests 9

Cartridge volume

Commercial cartridge volume

2016 over 7.5 times 2015

volume

2016 volume approx. 25,000 cartridges

Of which

CE-marked tests 3

Of which

CE-marked tests 4

Page 20: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Product revenues increased with 88% in 2016

20

Breakdown total operating income

In EUR 1,000 2016 2015

Cartridge sales 4,015 1,294

Idylla™ system sales 2,752 2,299

Product sales revenue 6,767 3,593

R&D services 255 662

Upfront license revenues 4,691 5,025

Milestone revenues 332 4,000

Collaboration revenue 5,278 9,686

Service revenue 53 54

Total revenue 12,098 13,334

Grants and other income 1,674 1,617

Total operating income 13,772 14,951

Remarks

Product sales by type

• Cartridge sales increased with 210% and system sales with

20%

• Collaboration revenues decreased as EUR 4m one-off

milestones were collected in 2015 (versus EUR 332k in 2016)

• Grants and other income consisted of recognized grant

income for R&D project support

84%

16% Commercial

R&D partners

2016 2015

71%

29% Commercial

R&D partners

Page 21: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Net result of EUR (49.8)m in 2016

21

Condensed income statement Remarks

• Excluding cost of sales, operating expenses increased in

2016 with 12% to EUR 58.2m

• R&D: increased due to higher staff (and related) costs

and increased R&D activities for test and platform

development, partially offset by lower expenses for

subcontracting

• S&M: increased due to an expansion of the S&M team and

increased sales and promotional expenses

• G&A: decreased due to less expenses for external advice*,

facilities & office and human resources, partially offset by

increased staff costs

• Income taxes consist of research and development tax

credits that Biocartis received in Belgium

In EUR 1,000 2016 2015

Total operating income 13,772 14,951

COGS (5,701) (2,642)

R&D expenses (42,091) (36,554)

S&M expenses (10,324) (8,747)

G&A expenses (5,827) (6,662)

Total operating expenses (63,943) (54,606)

Operating result (50,171) (39,655)

Net financial result (586) (790)

Income taxes 980 648

Net result (49,777) (39,797)

* 2015 was exceptionally impacted by the Company’s IPO in April 2015

Page 22: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Cash position end of 2016 of EUR 83.2m

22

Condensed cash flow statement Remarks

• Cash flow from operating activities impacted by

– A lower result for the period, predominantly due to higher operational expenses

– Investments in working capital for 2016 versus significant positive movements in working capital for 2015

• Cash flow from investing activities increased due to

– Increased investments for the cartridge manufacturing expansion

– Higher investments in intangible assets related to platform development

• Cash flow from financing activities includes

– Net proceeds private placement November 2016 of approx. EUR 31m

– Proceeds from new borrowing, partially offset by repayments of borrowing that were due end 2019

• Financial debt (current portion of EUR 3.7m) includes

– New subordinated loan of EUR 15m

– Lease financing for cartridge manufacturing facilities

In EUR 1,000 2016 20152

Result for the period (49,777) (39,797)

Depreciation and amortisation 5,055 5,094

Other adjustments 109 (172)

Operational burn rate (44,613) (34,875)

Working capital changes (8,699) 7,540

CF operating activities (53,312) (27,335)

CF investing activities (9,342) (5,436)

CF financing activities 41,804 125,943

Total net cash flow (20,850) 93,172

Cash and cash equivalents1 83,247 104,087

Financial debt 31,407 10,815

1. Including EUR 1.2 million restricted cash related to KBC Leased financing 2. The presentation of the consolidated cash flow statement of the year ended 31 December 2015 has changed compared to what has been published in the annual report of 2015, predominantly related to activities for

cartridge manufacturing expansion. The implemented changes were all qualified as reclassifications. Details will be included in the 2016 annual report

Page 23: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

23

Guidance 2017

250 - 275 expected installed base expansion in 2017

Forecasted total installed base of Idylla™ instruments around 640 by year-end

Guidance target cash position by end 2017 of around EUR 40m

Commercial cartridge volume in 2017 to be at least three times 2016 volume

Page 24: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

24

Expected menu newsflow 2017

• CE-marking Idylla™ EGFR Mutation Test (Q2 2017)

• CE-marking Idylla™ NRAS Mutation Test (Q2/Q3 2017)

• CE-marking Idylla™ ctKRAS Mutation Test (H2 2017)

• CE-marking Idylla™ ctNRAS-BRAF Mutation Test (H2 2017)

• Launch Idylla™ ctEGFR Mutation Assay (RUO, H2 2017)

• US FDA 510(k) approval of the Idylla™ platform in conjunction with Idylla™ IFV-RSV Panel Test

Page 25: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

25

Financial calendar 2017

• Publication annual report 2016 30 March 2017

• Q1 2017 business update 27 April 2017

• Annual General Meeting 12 May 2017

• H1 2017 results 7 September 2017

• Q3 2017 business update 16 November 2017

Page 26: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Shareholder >3% table # shares % shares

Johnson & Johnson Innovation 6,107,518 13.7%

Debiopharm Diagnostics 4,749,707 10.6%

RMM 3,989,058 8.9%

Benaruca 2,542,408 5.7%

BIOSPV 539,834 1.2%

PMV-TINA 1,840,861 4.1%

Participatie-Maatschappij Vlaanderen 428,000 1.0%

Topbio1 1,804,644 4.0%

Hitachi Chemical 1,417,346 3.2%

Sycomore Asset Management 1,343,909 3.0%

Other institutional and retail investors 19,884,820 44.5%

Total outstanding shares (non-diluted) 44,648,105 100.0%

Shareholders, stock performance and coverage

Shareholder overview (as per 14 December 2016) Share performance 2016*

Coverage

26 * Source: Euronext

Note: see website Biocartis for more details

Page 27: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Appendix

27

Page 28: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Unsurpassed ease of use and fast time-to-result

SCAN SAMPLE

SCAN CARTRIDGE

LOAD SAMPLE INSERT CARTRIDGE

35 to 150 minutes

Offering potential for CLIA waiver

28

Page 29: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Unique position in MSI testing

What is Microsatellite Instability?

• MSI evolves as a result of the so-called ‘inactivation of the body’s DNA mismatch repair (MMR) system’

• Consequently, errors that normally spontaneously occur during DNA replication are no longer corrected, resulting potentially in tumor growth

• Tumors can be labeled as MSI-High (MSI-H), MSI-Low (MSI-L) or Microsatellite Stable (MSS)

• MSI is a proven prognostic oncology biomarker included in CRC guidelines and found in different cancer types: Cancer type % MSI-H

Colorectal 10-20%1

Endometrium ± 30%2

Ovarium 5-10%3

Melanoma ± 10%4,5

Cancer type % MSI-H

Lung ± 5%6

Gastric ± 20%7

Pancreas ± 15%8

1 Boland et al, Gastroenterology 2010; 2 Cancer Genome Atlas Research Network, Nature 2013; 3 Singer et al, Int J Cancer 2004 ; 4 Uribe et al, Am J Dermatopathol 2005; 5 Ninomiya et al, British Journal of Cancer 2006; 6 Kroiss et al, Acta Derm Venereol 2001; 7 Cancer Genome Atlas Research Network, Nature 2014; 8 Nakata et al, Clin Cancer Res 2002

Biocartis’ unique position in MSI

• Exclusive license agreement with the Flemish Institute for Biotechnology for rt-PCR compatible MSI markers

• Strong competitive position of Idylla™ based MSI testing versus current manual and complex procedure using capillary electrophoresis (Bethesda method), requiring multiple days to perform

• Idylla™ MSI test does not require sample control; 1 sample per patient required

IdyllaTM MSI test initially positioned as prognostic biomarker for colorectal cancer

29

Page 30: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Extending scope of Idylla™ MSI test to immunotherapy

Potential to predict immunotherapy response Study example (Le et al, NEJM 2015)

Microsatellite High Microsatellite Stable

Pro

babili

ty o

f

Pro

gre

ssio

n F

ree S

urv

ival

Months

Lower progression rate in MSI-H patients10 to PD-1

immune checkpoint blockade with

pembrolizumab (Keytruda)

• Immunotherapies for oncology are shown to have a positive impact on long term survival, especially in combination with targeted oncology therapies

• Immunotherapies focus on fighting cancer cells via the body’s immune system and consist of 3 major approaches:

– Cancer vaccination

– CAR-T-cells (manipulation of immune system to recognize and attack cancer)

– Immune checkpoint blockade (blocking ability cancer cells to downregulate activity immune system)

• Recent data show that a tumour’s MSI status may predict a

patient’s response to certain immunotherapies

• Scope of the Idylla™ MSI test will be broadened to capture expected value of MSI for predicting response to certain immunotherapies

30

Page 31: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Idylla™: first line testing and gateway to NGS in oncology

Gene alterations*

* Source: Dienstmann, Salazar, and Tabernero ASCO EdBook 2015 and www.mycancergenome.org. ** Normanno et al. J Transl Med (2015); Patton et al. BJC (2014); Zhang et al. Clin Chem Lab Med (2014)

Idylla™ positioning

• Idylla™ solid and liquid oncology menu guides treatment decisions for majority of cancer patients:

– Focus on comprehensive panels for actionable biomarkers (linked to gene alterations)

– Fully automated and fast turnaround times

– Enables rapid triaging and same-day treatment

• Comprehensive genome profiling techniques like next-generation sequencing (NGS) to be used for detection of less common alterations that can guide alternative treatments or off-label use

• Challenges NGS to be overcome before widespread clinical use:

– Complex batch-based workflows and high costs

– Lack of standardisation can lead to wrong treatment decisions, similar to classical qPCR-based testing**

Mela

nom

a

Colo

n

BRAF

NRAS

Other

KRAS

NRAS

BRAF

MSI

Other

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Page 32: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

NGS sample and library preparation revisited

* TaT: total turnaround time ** Based on common NGS workflows and management estimates

3.5h 1.2 days

Idylla™ NGS Prep Panels: • Standardisation and automation of key sample and library preparatory steps • Any sample type • Reduction of total hands-on and turnaround time of 50%-75%**

typic

al N

GS w

ork

flow

sample prep NGS library

prep sequencing

hands-on TaT*

2.5h 5h

3.5h 7h

Full NGS prep summary

4 #labs

6h hands-on

3 #PCR reactions

6 #auxilliary devices

18 #samples/ batch

12h Turnaround time

• Isolate genomic material from clinical sample

• Quantify genomic material via qPCR

• Target amplification via PCR

• Indexing and tagging via PCR

• Purification

• Pool libraries • Sequencing • Data analysis

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Page 33: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

Sample to result for every patient

Actionable biomarkers

Immediate treatment with personalised

medicine

Absence actionable biomarkers

Automated and standardised

gateway to NGS

• Idylla™’s comprehensive panels for most commonly mutated genes guide treatment decisions for the majority of cancer patients

• For those cancer patients with more complex genomic alterations, Idylla™ NGS Prep Panels function as a gateway to comprehensive MDx testing

• Like for qPCR-based testing, Idylla™ offers the opportunity to revolutionise NGS workflows by:

– Standardisation

– Automation

– Shorter time-to-results

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Page 34: Biocartis Corporate Presentation...•Biocartis to establish a US subsidiary and local team to support US commercialization in H1 2017 - commercial roll-out expected in H2 2017 •World

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Contact

Biocartis Investor Relations Generaal de Wittelaan 11 B3

2800 Mechelen

Belgium

tel. +32 15 63 17 29

[email protected]

www.biocartis.com

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