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Competing for CapitalBiocartis case study
27 October 2016Vlerick Healthcare Conference
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.
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. Unless required by applicable law or regulation, 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 of operations, financial condition, liquidity, 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 of operations, financial condition, liquidity, 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 of operations, financial condition, liquidity 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 shares 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
Intern becomes CFO
Ewoud Welten, afkomstig van de investerings bank Kempen & Co, neemt haar plaats als financieel directeur in. De manier waar op hij daar te recht kwam, is op merkelijk. Kempen & Co laat zijn bankiers toe om eens over de muur te kijken en stage te lopen bij een bedrijf. 'Ik draaide hier vorig jaar vier maanden mee, en heb zelfs een deel van de voor bereidingen op de beurs gang mee gemaakt', zegt Welten. 'Het is uitzonderlijke maar ideale manier om te recruteren', zegt Win dels.
4
High precision diagnostics for high precision medicine
• ‘First time right’ molecular diagnostic system
• Combining advantages of point of care testing with performance of reference testing
EARLY DIAGNOSIS THERAPY SELECTION PATIENT MONITORING
• Rapid diagnosis • High sensitivity• Comprehensive panels
• Treatment guidance• Companion diagnostics
• Monitoring of treatment progress
• Early detection of relapse IdyllaTM
5
IdyllaTM best-in-class
• Fully automated sample-to-result
• Accurate results at right sensitivity
• High levels of multiplexing
• Short turnaround time
• Modular
• Connectivity
6
Inst
rum
ent
Conso
le
Disposable cartridge
Limitation of erroneous results due to standardisedcartridge
• 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
7
Idylla™ follows a razor-razorblade model
8
• Cartridge consumption on Idylla™ instruments is 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
Rapidly expanding test menu
9
10
Menu for oncology and infectious diseases
1. Source: Markets & Markets: In Vitro Diagnostics (IVD) Market by Product Technology (Immunoassay, Clinical Chemistry, Molecular Diagnostics, Hematology) by Application (Diabetes, Cancer, Cardiology, Autoimmune Diseases) - Forecast to 2020
2. FFPE is abbreviation of Formalin-Fixed Paraffin Embedded
Oncology Infectious diseases
Fastest growing segment of the MDxmarket1 - CAGR of 17% between 2015-2020
Largest segment of the MDx market1 –44% of total in 2015
• Direct processing of FFPE2 tumour slices
• Highly sensitive detection of a vast range of mutations from tissue or blood
• Ability to offer syndromic panels that include quantitation
• Short turn around times combined with high sensitivity
• Sample enrichment platform for sepsis application
• Solid biopsies and liquid biopsies
• First wave of tests based on clinically proven and reimbursed biomarkers
• Second wave to include new proprietary biomarkers
• Syndromic panels (e.g. respiratory tract panel assays)
• Disease surveillance
• Sepsis
• Viral load assays
USPs
Focu
s
PARALLEL MENU EXPANSION
Strategic partnerships
(Focus on CDx development)
(Initial tests include Flu-RSV)
Diagnostic app developer partnerships
Our diagnostic app store
On market 2016 2017 Focus 2018 - 2020
ON
CO
LO
GY
INFECTIO
US
DIS
EASES
KRAS CE (colon)
BRAF CE (melanoma)
NRAS / BRAF / EGFR492 RUO (colon)
IFV-RSV Panel CE+
ctBRAF RUO (melanoma)
Intention to launch at least 4 tests per year
CE = CE-marked tests. RUO = Research Use Only. EUA = Emergency Use Authorisation label + JnJ test ++ Fast-track Diagnostics development
Note: overview is subject to changes in prioritisation of test development driven by several factors such as commercial and operational considerations. Overview excludes regional expansion (as of 2017), life cycle management and potential partner tests.
Onco Solid Biopsy
Onco Liquid Biopsy Infectious
5
LCP~ RUO (lung)
Ebola EUA
ctKRAS RUO (colon)
ctNRAS / BRAF / EGFR492 RUO (colon)
NRAS CE (colon)
NRAS/BRAF CE (colon)
LCP~ CE (lung)
MSI (colon)
ctKRAS CE (colon)
ctNRAS / BRAF CE
(colon)
Respiratory MP++
NGS Prep Panel I
IdyllaTM Retrieve
NGS Prep Panels (second panel in 2018)
10 14 Around 30 assays on market by 2020
# unique tests on market
IFV-RSV 510k submission+
Sepsis (initial launch in 2018)
MERS++ Meningitis++
Solid biopsies• Fusions (ALK/ROS…)
• Amplification (Her2/Met…)
(Pan tumour panels)
• Immuno TX Panel• Neuro Panel• HPV (head & neck)
Liquid biopsiesLung, colon and breast cancers: easy diagnostic inclusion and monitoring of resistance to therapy
Syndromic panels: e.g. Tropical Fever and Immunocompromised panel
Viral load assays: HIV+, HBV and HCV
~ LCP = lung cancer panel11
12
106 Idylla™ instruments added to installed base
82
27183
165
106
2014 Increase2015
31-Dec-15 IncreaseH1 2016
30-Jun-16
Installed base development
• Key drivers behind growth H1 2016:o Oncology menu expansion end 2015 (doubling
number of oncology tests to four)o Launch of Idylla™ EGFR Mutation Assay* end
Q2 2016
• Significant number of new installations placed with customers towards end of Q2 2016
• Majority of new placements in H1 2016 with customers in Europe
* The Idylla™ EGFR Mutation Assay is intended for Research Use Only, not for diagnostic procedures. Not for sale in the USA and Canada.
Remarks
13
Razor-razorblade approach in numbers
30 June 2015 30 June 2016
Installed baseIdylla™ instruments: 114
Number Idylla™ tests on market: 2
Installed baseIdylla™ instruments: 271
Number Idylla™ tests on market: 7
Cartridge volume
Commercial cartridge volume H1 2016 > 2x volume 2015 full year
Idylla™ KRAS Mutation Test top selling product in H1 2016, followed by Idylla™ BRAF Mutation Test
Increase in product revenues of 63%
Breakdown total operating income
In EUR 1,000 H1 2016 H1 2015
Idylla™ System Sales 988 1,246
Cartridge Sales 1,723 416
Product sales revenue 2,711 1,663
Collaboration revenue 3,377 4,866
Service revenue 20 48
Total revenue 6,109 6,577
Grants and other income 641 646
Total operating income 6,750 7,224
40%
50%
0%10%
Product sales revenue
Collaboration revenue
Service revenue
Grants and other income
H1 2016 H1 2015
23%
67%
1%
9%
Product sales revenue
Collaboration revenue
Service revenue
Grants and other income
14
How did Biocartis finance itself?
Started with private financing rounds
Historical financing rounds Pre-IPO shareholder base (% TOTAL SHARES)***
RMM
Benaruca
20%
14%
12%
8%
7%
5%
5%
4%
4%
3%
3%
3%
Padoki
*** Assuming completion of the entire Series F financing round and on a non-diluted basis. Other investors (12% in total) are:
Wellcome Trust, Advent, Petercam and other family offices
Round Date Amount
Foundation Jul. 2007 € 62,500
Seed Capital Jul. 2008 € 1.25 M
Series A Oct. 2009 € 10.0 M
Series B Apr. 2010 € 44.0 M
Series C Nov. 2011 € 58.6 M
Series D Dec. 2012 € 34.5 M
Series E Nov. 2013 € 30.0 M
Series F1* Nov. 2014 € 21.5 M
Series F2 Jan. 2015 € 21.5 M
Total** € 221.4 M
Series F3 IPO pre-commitment € 21.5 M
* In August 2014 the investment agreement of the F-round financing was signed: EUR 64.5
million (in 3 equal tranches) was committed
** Includes MyCartis; historical investment approx. EUR 40m
16
Joined forces with strategic partners
Strategic partnerships Diagnostic app developer
partnerships
17
Oncology
Infectious Diseases
Attracted grants
18
Project Taurus
19
Intention to float on fool's day
Global Coordinator and Joint
Bookrunner
Joint Bookrunners
20
Listing venue Euronext Brussels
21
IPO launched on April 15
Price range set at
EUR 10.0 – 11.5
Max. potential proceeds of EUR 115m
Successful IPO raising EUR 115m
23
Strong investor demand
Total demand for EUR 650m
~6.5x over-subscribed
* Excluding pre-commitment and retail
24
Key success factors?
Compelling equity story External validation EU and US investors Market conditions
26
Listing consequences
• Access to additional sources of funding
• Liquid shares
• FOCUS
• A smaller board
The good things The flip side
• The share price
• Disclosure price sensitive information
• Reporting obligations
• Management time
Selection
27
Funding manufacturing expansion• Manufacturing instrument and console successfully
outsourced in to a contract manufacturing organisationwhich enabled:
– realisation of significant cost efficiencies
– required scaling of production capacity
• Biocartis currently operates one cartridge manufacturing line that is located in Mechelen (Belgium)
• Over 150,000 cartridges manufactured to date
• Capacity current line is being ramped up by adding workstations and implementing additional shifts in 2016
• Equipment and tools of a new higher capacity line ordered end of 2015. This second line should be operational in 2017
28
EUR 55m debt financing announced in July 2016
Lease financing(EUR 15m)
Credit lines(EUR 25m)
Subordinated loan
(EUR 15m)
• To fund the equipment of a second Idylla™ cartridge manufacturing line
• To fulfil certain future financing needs in, amongst others, working capital
• Consisting of a EUR 15m rollover credit line and EUR 10m working capital credit line
• Partially guaranteed by Gigarant+
• To refinance the company’s current subordinated loan of EUR 5m (excluding accrued interest charges) due end of 2016
Element Providers Background Inclusion
• ~ EUR 5m drawn as per 30 June 2016
• Not included in H1 2016 accounts as signed after 30 June 2016
• Not included in H1 2016 accounts as signed after 30 June 2016
* ~
* Flemish Investment Company ‘ParticipatieMaatschappij Vlaanderen’~ Belgian ‘Federal Holding and Investment Company’ (FPIM)+ Guarantee by Flemish Government through Gigarant
What is next?
30
Operational cash flow
Non-dilutive financing
Debt Equity
Financing spectrum
31
What tools are currently available
Equity
Mezzanine
• Issue ordinary shares
Lease financing
SEDA• Standby equity distribution agreement
• Subordinated loan senior to equity only
• Sale and lease back of assets
Equity
Debt
Working capital financing
• Debt financing used for working capital purposes
Selection
32
What are future debt financing tools?
Size cash flow
Pre
dic
tabili
ty c
ash
flo
w
Convertible bond
Private placements
Senior corporate
loan
Listed bonds
…
Selection
Questions?
33