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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, solicitationor 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 inconnection 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 inconnection 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, speaks as of today, and is subject to updating, completion, revision andamendment and such information may change materially from time to time. No person is under any obligation to update or keep current the information contained in this presentation andany 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 orcompleteness 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 presentationor 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 otherfactors 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 differmaterially from those expressed in, or suggested by, these forward-looking statements. The Company cautions you that forward-looking statements are not guarantees of future performanceand 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-lookingstatements 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 areconsistent 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 Companyand 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 inthis 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 requiredby 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 orlocated 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 registrationor 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 informthemselves 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 absentregistration under the Securities Act or exemption from the registration requirement thereof.
Since the COVID-19 outbreak in December 2019, it has developed into a pandemic, causing significant disruptions to the global economy, including in certain countries in which the Companyis operating its business. During H1 2020, the Company has experienced a slow down of its commercial activities and delays of certain partner projects as a result of various measures takento contain the spreading of the virus.The extent to which the pandemic will continue to affect the Company’s operations will depend on future developments, which are highly uncertain andcannot be predicted with confidence, including but not limited to the duration of the pandemic, the severity and resistance of the virus and the actions taken to contain the virus or treat itsimpact. In particular, and although the Company currently expects that significant demand for its pandemic response products could mitigate the impact of COVID-19 on its oncology business,the continued spread of the virus could adversely impact its operations, including among others, the manufacturing and supply chain, sales and marketing and collaboration activities withpartners, and could have an adverse impact on the Company’s business and financial results.
31 In collaboration with Immunexpress. Immunexpress Pty Ltd (‘Immunexpress’) is a Seattle-based molecular diagnostic company; 2 In collaboration with multiple undisclosed partners; 3 Guangzhou Wondfo Biotech Co., Ltd. (‘Wondfo’, SHE: 300482) is a fast growing diagnostics leader in China; 4 Defined as the world excluding European direct markets, US, China and Japan
Differentiated technology
Unique Idylla™ technology in oncology, partnering strategy in
infectious diseases
Attractive market
Worldwide commercial footprint
Commercially proven, COVID-19 agility &
resilience
Positioned for further value creation
• Idylla™: first fully automated sample-to-result qPCR platform• Superior and continued validated performance versus competition• Enabling global decentralization of clinical molecular diagnostics (MDx)
• Cartridge volume ramp-up fueled by continued menu expansion through internal menu development, additional product registrations (including US FDA filings) and menu partnerships, the latter further growing the partner eco-system
• Ongoing geographical expansion (penetration in US market, initiation of commercialization in China & Japan)
• New highly automated second cartridge manufacturing line to support volume growth and cost effectiveness
• Unique platform features bring strong competitive advantage in oncology testing, broad test menu (solid & liquid biopsies) currently focused on targeted therapies &immunotherapy, move into monitoring
• Validation via oncology partnerships with pharma (e.g. Amgen, Merck KGaA, AstraZeneca, Bristol-Myers Squibb, Kite/Gilead) • New pandemic response test menu in H2 2020 with SeptiCyte(R) RAPID on Idylla™1 and Idylla™ SARS-CoV-2 Test2, leading the way for longer term sustainable strategy
towards development of an infectious disease menu with partners• New generation of Idylla™ FLEX assay products: faster, easier and more cost effective development, paving the way to liquid biopsy surveillance monitoring
• Direct sales approach in US, Canada and Western Europe
• Strategic partnerships established for China & Japan: joint venture with Wondfo3 (China) and commercial collaboration with Nichirei Bio (Japan)
• Distributor markets3 model: partnerships with local distribution partners for relevant RoW4 MDx markets supported by Biocartis RoW sales team
• Installed base of 1,581 Idylla™ instruments as per 31 December 2020, +335 new placements in 2020• Commercial volume of 230k cartridges in 2020, representing a +31% year-over-year growth despite COVID-19• Resilience & agility against COVID-19 impact with new Idylla™ pandemic response test menu• During 2020, expanded (AstraZeneca, BMS) and new partnerships in oncology (GeneproDx) & infectious diseases (Immunexpress, LifeArc, BMS, Endpoint Health)
• Global MDx market of USD 6.5bn; oncology fastest growing segment with high double digit annual growth rates• Large, global customer base (in pathology labs) with opportunity to expand (e.g. labs that want to step into MDx testing) • Diversification into infectious disease market: new pandemic test menu as hedge strategy against COVID-19 impact, longer term strategic opportunity to sto
support the patient journey in the intensive care unit (ICU), including rapid triage and therapy selection of critically ill patients
4
• In the US, nearly 80%4 of
cancer patients do not have
genetic mutation results
available at initial oncology
consultation
• Up to 25% of patients begin
treatment before receiving
their results4
UK2 | 14-30 days
AUSTRALIA5
Median 17 days20% more than 4 weeks
USA1
Median 27 daysRange: 14-77 days
FRANCE3,4
21-28 days26% more than 4 weeks
Source: 1 Schwaederle et al. (2014) Oncologist 19, 631 – 636; 2 Saunders et al. ESMO 2016, Abstract #; 3 INCa 2012 Survey, 3 Etude FLASH RAS 2014; 4 JMD, May 2017; 5 Scott et al. (2014) Asia Pac J Clin Oncol. 10(3):261-5.
5
Inst
rum
ent
Conso
le
Cartridge(consumable)
Scan sample
Scan cartridge
Loadsample
Insert cartridge
Clinically-actionable
results
Superior sensitivity and ease-of-use,
combined with sample-to-result turnaroundtime of 65 to 160 minutes*
Unique, versatile platform for dual use in
oncology and infectious disease
* Based on turnaround times of current on-market oncology tests
Traditional workflow*Idylla™ workflow
1
Instruments needed
Lab consumables needed
Lab infrastructure (# rooms) 3Workflow • Fully automated (‘sample-to-result’)
and on demand• Manual and batch-based testing,
1/week or biweekly
Traditional workflow results in:• Centralized testing (many labs send out
samples) by specialized labs with experienced lab technicians
• Poor reproducibility of results (i.e. human errors)
• Long turnaround time (~ weeks)
Idylla™ enables: • Decentralized testing by all labs (no
geographical differences in quality)• ‘First-time-right’ results • Short turnaround time (~ ‘same-day-
result’)
* Based on a qPCR workflow** Example for France, based on a survey conducted in 5 French regions by the French National Cancer Institute, January 2016 (http://en.e-cancer.fr)*** Idylla™ CE IVD Tests are intended to aid in the assessment of patients with cancer for their mutation status and to facilitate treatment decisions with a multidisciplinary team
• < 2.5hrs turnaround time per test• In 1-2 days to treatment
initiation***
• 1-4 days turnaround time per test• On average 18 days** to treatment
initiation***
Turnaround time
6
• Comparison of 13 different KRAS mutation detecting technologies:
• Focused on detection of KRAS mutations in lung cancer based on blinded samples
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*)o Highest score for Idylla™ KRAS technology on total
turnaround time (2 to 4 hours versus 1 day to 3 weeks)
Background
Source: Sherwood JL, Brown H, Rettino A, et al., “Key differences between 13 KRAS mutation detection technologies and their relevance for clinical practice”. ESMO Open 2017;2:e000235. doi:10.1136/ esmoopen-2017-000235NGS technologies included two technologies by Thermo Fisher Scientific. Mass spectrometry technologies included two technologies from AgenaBioscience
Conclusions
6x NGS
3x qPCR
2x mass spec.
1x ddPCR
1x Sanger sequencing
Sensi
tivity
Technology Overall sensitivity
Idylla™ KRAS 96%
Other qPCR (cobas/therascreen) 46-52%
Mass-spectrometry 58-92%
NGS 48-100%
ddPCR 52-60%
Ease
-of-
use
TaT**
* One being the lowest level of expertise and four the highest** TaT = total turnaround time7
8
Only selected studies shown on slide
1 Including publications, abstracts and posters and e-publications ahead of print. Sources can be found in the H1 2020 results press release on https://investors.biocartis.com/en/press-releases or see www.biocartis.com/publications ; 2 Led by researchers from Dartmouth’s and Dartmouth-Hitchcock’s Norris Cotton Cancer Center (Lebanon, New Hampshire, US). Tsongalis et al., “Comparison of Tissue Molecular Biomarker Testing Turnaround Times and Concordance Between Standard of Care and the Biocartis Idylla Platform in Patients With Colorectal Cancer”, Am J Clin Pathol. 2020 Jun 11;aqaa044. doi: 10.1093/ajcp/aqaa044. Online ahead of print; 3 The virtual annual ASCO 2020 meeting took place between 8-10 August 2020; 4 The ‘European Society for Medical Oncology’ congress took place between 19-21 September 2020. The FACILITATE study can be found here; 5 In Belgium, France, Germany and Italy. The study aimed to prospectively test 100 paraffin-embedded biopsy or cytology tissue samples with ≥10% neoplastic cells per site, from patients with advanced NSCLCaimed to prospectively test 100 paraffin-embedded biopsy or cytology tissue samples with ≥10% neoplastic cells per site, from patients with advanced NSCLC; 6 Announced on 29 November 2018, see here ; 7 Association for Molecular Pathology congress is a leading molecular diagnostics conference that took place virtually this year between 16-20 November 2020; 8 RUO = Research Use Only, not for use in diagnostic procedures; 9 A. Velasco et al., Multi-center real-world comparison of the fully automated Idylla™ microsatellite instability assay with routine molecular methods and immunohistochemistry on formalin-fixed paraffin-embedded tissue of colorectal cancer, Virchows Archiv, https://doi.org/10.1007/s00428-020-02962-x, November 2020
Virtual annual ASCO (American Society of Clinical Oncology) 2020 meeting3
Publication of five Idylla™ abstracts & posters by key oncology opinion leaders
Including first Idylla™ data from China where amongst others the Idylla™ EGFR Mutation Assay (RUO) showed excellent concordance with other methods
Published in the ‘American Journal of Clinical Pathology’2
Demonstrated that, compared tocurrent standard-of-care testingmethods, Idylla™ can substantiallyimprove turnaround time of theresults of mutation testing,independent of the size of the
laboratory
One of the largest studiesperformed involving Idylla™: incl. 20labs of different types & sizesthroughout US & Puerto Rico anddata from ca. 800 colorectal cancersamples
New US multicenter study ASCO
H1 2020 publication1 highlights
FACILITATE study selected for
presentation at 2020 ESMO Virtual
Congress4
Large, prospective, real-world data set
study across 16 European sites5
(launched as part of the agreement
between Biocartis & AstraZeneca6) aimed
at obtaining faster lung cancer MDx
biomarker results in Europe
Study concluded that Idylla™ reduced
turnaround time by 10 days versus
reference methods, allowing earlier
patient management decisions
H2 2020 publication highlights
AstraZeneca’s FACILITATE study at Virtual ESMO congress4
10 Idylla™ studies at AMP7
Global MSI multicenter
study
Highlighted strengths of Idylla™ platform and assays in terms of performance, ease of use & turnaround time
Idylla™’s capacityto overcomeobstacles ofworking with smallamounts of sample
Demonstratedexcellentperformanceof Idylla™ MSIAssay8 withvery lowfailure rate
Study waslargest so farpublished forBiocartis
• Oncology focus:
• On market Idylla™ oncology test menu in colorectal, lung, melanoma, with ongoing developments in breast and thyroid cancer
• Selected opportunities to broaden and deepen in oncology
• Pan-cancer opportunities
• Improving with the Idylla™ FLEX technology
• Expansion into new areas: endometrium, brain and hematological cancers
• Expansion in infectious diseases:
• More diversified Idylla™ test menu to accelerate further installed base growth
• Driven by the current pandemic testing needs
9Please see the Idylla™ oncology pipeline for all details on the development & regulatory status of assays. The Idylla™ oncology pipeline reflects the different cartridges and biomarkers in development, including cartridges that can be used for research applications. Please see here for more information about the respective studies, or to the specific product labeling for applicable intended use for each individual Biocartis product. All publications, abstracts & posters are available on www.biocartis.com/publications. Overview is subject to change in amongst others prioritization of test development by Biocartis and/or partners driven by commercial, partnering & operational considerations. The Idylla™ GeneFusion Assay (RUO) & Idylla™ GeneFusion Panel (IVD) are currently under development. NTRK1-3 will be only available in the Idylla™ GeneFusion Assay (RUO). Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc.; ABC = Advanced Breast Cancer; IO = Immuno-oncology; FNA = Fine Needle Aspirates
NEW
KRAS (CE-IVD)
NRAS-BRAF (CE-IVD)
ctKRAS (RUO)
ctNRAS-BRAF (RUO)
MSI (CE-IVD)
EGFR (CE-IVD)
ctEGFR (RUO)
BRAF (RUO)
KRAS (RUO)
GeneFusion (in development)
EGFR/BRAF+ (in development)
BRAF (CE-IVD)
ctBRAF (RUO)
NRAS-BRAF (RUO)
Idylla™ ABC Assay
(in development)
KRAS (pancreatic cyst fluid samples)
NRAS & BRAF (thyroid FNA samples)
MSI (pan-tumor)
IO: MSI (in development)
IO : Cell therapy
monitoring (in development)
Endometrium
(to develop)
Hematology
(to develop)
Brain
(to develop)
Idylla™ oncology menu
Melanoma Colorectal Lung
Breast Immuno-oncology Pan-cancer
ThyroidPrint®
on Idylla™
(in development)
Thyroid Endometrium Hematology Brain
10
Accelerate menu expansion
Increase installed base
Reduce costs, sharper pricing
Global Idylla™ ecosystem
Diversification
• What: porting of proprietary biomarker panels developed & validated by 3rd parties on Idylla™ platform
• For Biocartis: proprietary 3rd party content on Idylla™ platform, expanded menu appealing to larger audience
• For partner: accelerated global roll-out of content, focus on content education since no platform education needed, cost efficiencies
• What: (joint) development of CDx1 on Idylla™ platform
• For Biocartis: faster commercial adoption, higher market shares
• For partner: better & faster selection of eligible patients for targeted therapies given faster TaT& high sensitivity. Fast TaTreduces competition with therapies not requiring a biomarker, high sensitivity means more patients detected with relevant biomarkers
• What: development of Idylla™ assays with IVD development companies and research institutes
• For Biocartis: lowered menu development costs
• For partner: contribution to medical innovation, knowledge sharing & building
UK based medical research charity2
Singapore’s Agency for Science, Technology and Research3
1. CDx = Companion Diagnostics; 2. On 15 June 2017, MRC Technology changed its name in LifeArc. LifeArc has been involved in helping deliver a number of therapies including Keytruda (pembrolizumab, marketed by MSD) which is an important immunotherapy treatment for various cancers. On 1 September 2020, Biocartis announced the expansion of the partnership with LifeArc in the field of infectious and immune related diseases; 3. Partnership is with ETPL, the commercialization arm of A*STAR
Shared investment
Pharma & biotech partners
Content partners Development partners
A total of 335 new instrument placements, exceeding the latest guidance of 300new instrument placements. Biocartis’ installed base as per 31 December 2020increased to 1,581 Idylla™ instruments1
As per 31 December 2019, Biocartis’ cash position amounted to EUR 124m
(non-audited number) vs latest guidance of EUR 120m, stronger than expectedand allowing accelerated test menu expansion and diversification
Commercial volume of 230K cartridges, representing +31% growth, slightly ahead of the latest guidance of 30%
11 1 Excluding instruments returned by Exact Sciences in accordance with the termination agreement announced on 29 October 2020
12
Commercial cartridge volume
Installed base
Expansion oncology
partnerships
Test menu
1 In the US, distribution of the Idylla™ SARS-CoV-2 Test was initiated in Q3 2020 per US FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), May 2020, Section IV.C. Commercial Manufacturer Development and Distribution of Diagnostic Tests Prior to EUA Submission;2 Defined as the world excluding European direct markets, US, China and Japan; 3 Excluding instruments returned by Exact Sciences in accordance with the termination agreement announced on 29 October 2020; 4 A companion diagnostic (CDx) test is a test used as a companion to a therapeutic drug, that helpspredict if a patient is likely to respond to a treatment or not; 5 Metastatic colorectal cancer; 6 A molecular diagnostics company based in Santiago, Chile; 7 A Seattle-based (WA, US) molecular diagnostic company; 8 LifeArc, formerly known as the Medical Research Council Technology (MRC Technology, MRCT) is aLondon (UK) based life science medical research charity; 9 Aimed at improving, innovating and accelerating all aspects of COVID-19 testing, including research, regulatory oversight, clinical implications, reliability and access; 10 A Palo Alto, CA (USA) based company developing personalized care solutions and targetedtherapies for critically ill patients; 11 The Flanders organization for Innovation & Entrepreneurship. The Idylla™ GeneFusion Assay will include a highly multiplexed panel of established and emerging biomarkers, and will be the first FFPE (formalin fixed, paraffin embedded) RNA based assay on the Idylla™ platform;12 Developed in collaboration with Immunexpress
Cash position
• Year-on-year + 31% to 230k commercial cartridges: in line with pre-pandemic expectations despite significant COVID-19 impact in Q2 & Q4 • Moderate year-on-year growth in oncology despite significant disruption and de-prioritization of cancer care • In US: double digit year-on-year growth in oncology, boosted by strong demand of Idylla™ SARS-CoV-2 Test1
• In EU: consistent growth in oncology, only marginally below pre-pandemic expectations because of COVID-19 surge in Q4• In distributor markets2: declining volumes following continued impact of pandemic and currency depreciation in various distributor countries
• Biocartis’ cash position as per 31 December 2020 amounted to EUR 124m (unaudited figure), stronger than expected and allowing accelerated test menu expansion and diversification
• Growth of 335 new Idylla ™ placements, well in excess of latest guidance of 300• Strong US and EU demand for instruments in Q4 2020, fueled by the need for the Idylla™ SARS-CoV-2 Test1
• Total installed base of 1,5813 Idylla™ instruments as per 31 December 2020
• January 2020: master collaboration agreement with AstraZeneca aimed at rapid & easy testing, and expansion of partnership to, amongst others, the area of liquid biopsy testing using the Idylla™ ctEGFR Mutation Assay
• March 2020: expansion partnership with Bristol-Myers Squibb Company, to now also pursue, after the US, registration of the Idylla™ MSI test as a CDx test4 in mCRC5 in China
• November 2020: partnership with GeneproDx6 for the development of GeneproDx’s novel genomic test ThyroidPrint® on Idylla™
• EUR 1.2 million grant from VLAIO11 for the development of the Idylla™ GeneFusion Assay• Sept 2020: successful market release in Europe of CE-marked version of SeptiCyte® RAPID12 on Idylla™• Nov 2020: successful launch of CE-marked version of the Idylla™ SARS-CoV-2 Test1
Expansion infectious disease
partnerships
• March 2020: expansion of partnership with Immunexpress7 with co-commercialization agreement for SeptiCyte® RAPID test on Idylla™• Sept 2020: expansion of the partnership with LifeArc8 to now also develop assays in infectious and immune related diseases on Idylla™• Oct 2020: Biocartis joined the COVID-19 Testing Industry Consortium led by Bristol-Myers Squibb Company9
• Nov 2020: partnership with Endpoint Health10 for development & commercialization of novel CDx4 test on Idylla™ for critically ill patients
13
BIOCARTIS at an inflection point
• Our oncology customer base and franchise is ready for further scaling:
• Product excellence: demonstrated Idylla™ performance
• Commercial: global market access and expanding installed base due to commercial network, growing regulatory approvals Idylla™ platform & tests
• Operational footprint: growing manufacturing capacity while maintaining highest quality standards
• R&D efficiencies: leaner development processes
• First expansions in infectious diseases:
• Pandemic menu: Idylla™ SARS-CoV-2 Test and SeptiCyte®
RAPID on Idylla™
• First market access: sales force contracted premium accounts in EU & US
• Growing partner business model: optimizing partnering business model to accelerate core strategy
MARKET at a tidal shift due to pandemic
• A new ‘pandemic world’: supports current step-up in infectious diseases
• A unique opportunity: speed and simplicity of Idylla™ addresses current and future rapid response testing needs
• Evolution of testing needs: unique combination of oncology and infectious disease testing on one single platform
Idylla™ as a unique rapid, easy to use and highly accurate platform for dual use
in both oncology & infectious disease testing
14
1. Marketed by Roche. 2 Marketed by AstraZeneca. 3. Marketed by Merck KGaA and Eli Lilly. 4. Marketed by Amgen. 5. Marketed by Bayer (licensed from Eli Lilly’s Loxo). 6. Marketed by Merck. 7. Marketed by Roche.
• MDx tests detecting specific tumor mutations used for therapy selection in a specific cancer type
• Significant pharma pipeline of new targeted therapies
• Exampleso Zelboraf®1 (BRAF)o Tagrisso®2 (EGFR)o Erbitux®3 (RAS)o Vectibix®4 (RAS)
• Pan-tumor application of tumor mutation tests for therapies selected based on genetics rather than location of the tumor
• Allows therapy use across multiple cancer types
• Positive impact on underlying test volumes
• Exampleso Vitrakvi®5
o Keytruda®6
o Rozlytrek®7
• MDx tests based on RNA Gene Signatures are used for e.g.:o Diagnosiso Prognosis
• Often high value once validated & clinical value demonstrated
• Exampleso SeptiCyte® RAPIDo ThyroidPrint®
• MDx tests supporting immuno-oncology cancer treatments
• Consists of many different therapies, e.g.:o Immune checkpoint
inhibitorso Cell and viral therapieso Vaccines
• High unmet need for underlying MDx testing
• MDx tests via liquid samples
• Use in diagnosis, prognosis and Molecular Surveillance (i.e. therapy selection, response and recurrence monitoring)
• Can be done through off-the-shelf catalogue panels as well as tumor-informed, personalized panels
Diagnosis Treatment start Treatment stop
Molecular Surveillance
Prognosis & therapy selectionScreening & diagnosis
Response monitoring Recurrence monitoring
Gene signatures Targeted therapy Pan-tumor Immuno-oncology Liquid biopsy
KRAS
NRAS-BRAF
ctKRAS
ctNRAS-BRAF
MSI
15
Cartridge Development RUO USA
RUO = Research Use Only, not for use in diagnostic procedures; CE = CE-marked IVD; Product updates = Product updates to ensure IVDR compliance and implementation of Post-Marketing Surveillance feedback; ABC = Advanced Breast Cancer; IO = Immuno-oncology; FNA = Fine Needle Aspirates; PMA = Pre-Market Approval; 510(k) notification = a premarket submission made to the US FDA. Source: US FDA website. All publications, abstracts & posters are available on www.biocartis.com/publications. The Idylla™ GeneFusion Assay (RUO) & Idylla™ GeneFusion Panel (IVD) are currently under development. NTRK1-3 will be only available in the Idylla™ GeneFusion Assay (RUO). Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc.The Idylla™ development pipeline reflects the different cartridges and biomarkers in development, including cartridges that can be used for research applications. Please see here for more information about the respective studies, or to the specific product labeling for applicable intended use for each individual Biocartis product. Overview is subject to change in amongst others prioritization of test development by Biocartis and/or partners driven by commercial, partnering & operational considerations.
Ongoing
EGFR
ctEGFR
BRAF
KRAS
GeneFusion
EGFR/BRAF+
BRAF
ctBRAF
NRAS-BRAF
Idylla™ ABC Assay
PMA
CE Japan
PMA
China
510(k) Ongoing
Ongoing
Ongoing
Ongoing
Ongoing
KRAS (pancreatic cyst fluid samples)NRAS & BRAF (thyroid FNA7 samples) MSI (pan-tumor)4
IO: MSI
IO: Cell therapy monitoring
ThyroidPrint® on Idylla™ NEW
Endometrium NEW
Hematology
Brain NEW
NEW
Ongoing
Product update ongoing
Product update ongoing
Product update ongoing
Product update ongoing
Ongoing
Ongoing
Shared design & development project
= liquid biopsy
= solid biopsy
Ongoing
Product update ongoing
= planned start
= FLEX product
Legend
= on market
Ongoing
Ongoing
Ongoing
Ongoing
Product update ongoing
PMA Ongoing Ongoing
• Most common cancer worldwide: 13% of all cancers1, 85% are non-small cell lung cancers (NSCLC)2
• EGFR mutation testing: recommended in all patients with advanced NSCLC of a non-squamous subtype3
• Current lung cancer molecular testing is complex:
• Can take up to several weeks4, as labs often send out samples
• Samples often small, with limited amount of available lung tumor tissue
1. Navani et al. Lancet Respir Med (2015); 2. American Cancer Society. Global Cancer Facts & Figures 2nd Edition (2011); 3. NCCN Clinical Practice Guidelines in Oncology – NSCLC – Version 6.2017. Novello S. et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 2016; 4. Neal I. Lindeman et al. Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors, Guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology (2014); 5 *Idylla™ EGFR Mutation Test is validated for metastatic NSCLC (Non-Small Cell Lung Cancer)
Idylla™ ctEGFR Mutation Assay (RUO)
What is lung cancer?
1
Idylla™ EGFR Mutation Test (CE-IVD)
• Fully automated, directly on 1 FFPE tissue slice from metastatic NSCLC5
• Less than 2 minutes hands-on time• Covers 51 mutations in 1 single
cartridge • Approx. 150 minutes sample-to-result• Mutation detection for patient
management assessment
16
• Standard of care: slow, complex, costly
• Combination of different techniques (IHC, FISH & qPCR) to cover relevant biomarkers: many samples needed, time-consuming if tests are performed sequentially
• Next-generation sequencing (NGS)
• Stringent sample requirements: low sample quality & quantity might lead to high invalid rates
• Long turnaround time
• BioIT complexity is major hurdle
Existing testing in lung cancer
• Fully automated, directly on 2 ml plasma
• Approx. 2 minutes hands-on time• Covers 51 mutations in 1 single
cartridge • Approx. 160 minutes sample-to-result
The Idylla™ EGFR/BRAF+ Mutation Assay and the Idylla™ GeneFusion Assay can be used in a different sequential order. The Idylla™ EGFR/BRAF+ Mutation Assay and the Idylla™ GeneFusion Assay should be performed following international recommended guidelines. * The Idylla™ GeneFusion Assay and the Idylla™ EGFR/BRAF+ Mutation Assay will first be launched as RUO. The Idylla™ GeneFusion Assay (RUO) & Idylla™ GeneFusion Panel (IVD) are currently under development. NTRK1-3 will be only available in the Idylla™ GeneFusion Assay (RUO). Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc.; 1. NCCN Guidelines version 8.2020 Non-small Cell Lung Cancer; 2.; 3. FFPE = formalin fixed, paraffin embedded; 4 25% of NSCLC are KRAS and 41% of KRAS mutations is G12C. Source: Mol. Cancer 2018, M. Roman et al., KRAS oncogene in non-small cell lung cancer: clinical perspectives on the treatment of an old target
NEW: Idylla™ EGFR/BRAF+ Mutation Test*
• >60 targets in one single Idylla™ cartridge• Detects vast majority of actionable mutations in DNA• Targets include markers in EGFR and BRAF, as well as
a.o. KRAS G12C which covers ~41% of KRAS mutations in NSCLC4
• Completes the Idylla™ lung menu and extends partnering opportunities
TWO-STEP LUNG CANCER TESTING ON IDYLLA™
The Idylla™ EGFR/BRAF+ Mutation Assay & the Idylla™ GeneFusion
Assay intend to cover the vast majority of the actionable
mutations in NSCLC
+
1
NEW: Idylla™ GeneFusion Panel*
• Chromosomal translocations can produce gene fusions leading to uncontrolled tyrosine kinase activity
• Tyrosine kinase inhibitors are recommended by international guidelines1 for NSCLC patients with a specific gene fusion
• Idylla™ GeneFusion Assay: • Fully automated testing of ALK, ROS1, RET, MET exon 14,
NTRK1-3 in one single cartridge2
• Less than 2 minutes hands-on time with turnaround time of ~180 min using only 1 slice of FFPE3
17
Initial performance expectations as from early testing of prototypes. The Idylla™ call is a result of a preliminary decision tree algorithm.Idylla™ GeneFusion Assay (RUO) & Idylla™ GeneFusion Panel (IVD) are currently under development. Not all markers may be present in the Idylla™ GeneFusion Panel. Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc
18
Idylla™ vs comprehensive NGS panel Idylla™ vs amplicon-based NGS panel
• Comparator: comprehensive NGS technology, optimized for detection of gene fusions
• Strong agreement across all markers:- Overall Percentage Agreement: 97-100% - Positive Percentage Agreement: 93-100%- Negative Percentage Agreement: 97-100%
• Comparator: amplicon-based NGS technology
• Excellent agreement across all markers:- Overall Percentage Agreement: 99-100% - Positive Percentage Agreement: 100%- Negative Percentage Agreement: 99-100%
vs vs
1 FFPE sliceIdylla™ GeneFusion
Panel
1 FFPE slice
Idylla™ EGFR/BRAF+ Mutation Test
Patient management decision
1
2
NGS
Idylla™ in lung diagnostics, complementary to NGS
• Idylla™ as the go-to platform for fast results on actionable biomarkers, enabling rapid initiation of targeted therapy with minimal sample input and superior ease-of-use
• If no actionable biomarkers are detected with Idylla™, NGS can be performed to complete the profiling and support experimental therapies
19The Idylla™ EGFR/BRAF+ Mutation Assay and the Idylla™ GeneFusion Assay can be used in a different sequential order. The Idylla™ EGFR/BRAF+ Mutation Assay and the Idylla™ GeneFusion Assay should be performed following international recommended guidelines. Idylla™ GeneFusion Assay (RUO) & Idylla™ GeneFusion Panel (IVD) are currently under development. NTRK1-3 will be only available in the Idylla™ GeneFusion Assay (RUO). Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc.NGS = Next Generation Sequencing. A patient management decision is usually already made to provide immunotherapy if PD-L1 positive, without the need for NGS
+
-
Patient management decision
+
-
20
2
• Pan-tumor implies that therapy selection is driven by genetics rather than location of the tumor
• Allows therapy use across multiple cancer types
• Also pharmaceutical trials based on pan-tumor testing
• Positive impact on underlying test volumes
What is pan-tumor? Pan-cancer applications
• Idylla™ assays for research in pan-tumor applications
Idylla™ cartridge
• KRAS/NRAS/BRAF
• MSI
• GeneFusion
Select potential applications
• Lung, pancreas, breast
• Gastric, prostate, endometrial
• Gastro-intestinal, thyroid
Efficient access to pan-tumor setting: validation of existing products
MSI data from papers published in peer-reviewed journals
Colorectal
Endometrial
Gastric
Urinary tract
Duodenal pancreatic
Concordance: 93%-100%Sample size: 683
Concordance: 97%Sensitivity: 95%Specificty: 100%
Concordance: 97%Sensitivity: 96%Specificty: 100%
Concordance: 100%Sensitivity: 94%Specificty: 100%
Concordance: 100%Sensitivity: 94%Specificty: 100%
Farmkiss et al. JCP Oct 2020Pécriaux et al. JCP Jun 2020
Gilson et al. Sci Rep Oct 2020Pécriaux et al. JCP Jun 2020
Pécriaux et al. JCP Jun 2020
Pécriaux et al. JCP Jun 2020
Gilson et al. Sci Rep 2020; Mindiola-Romera et al. Exp Mol Path 2020; Malapelle et al Cells 2020: Pécriaux et al. JCP 2020; Zwaenepoel et al JMD 2020; Lee et al J Pat Trans Med 2019; Samasion et al JCP 2019; Li et al Clin Col Can 2019
21
3
Reinforcing existing oncology areas Entering new oncology areas
Test UseValue
proposition
Detection of the vast majority of actionable mutations in FFPE samples from patients with NSCLC, including a.o. EGFR, BRAF and KRAS G12C
Fast time-to-result, ease-of-use, sample versatility
Detection of MSI status in FFPE samples from patients with different cancer types
Easy (automation, sample-to-result), fast molecular test next to IHC
Names of Idylla™ Assays, Tests or Panels can be subject to change. Unless stated different, Idylla™ Assays are first launched as RUO assay. Idylla™ GeneFusion Assay (RUO) & Idylla™ GeneFusion Panel (IVD) are currently under development. Not all markers may be present in the Idylla™ GeneFusion Panel. Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130,
9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc
FFPE = formalin fixed, paraffin embedded; NSCLC = Non-small cell lung cancer; NGS = Next Generation Sequencing; IHC = Immunohistochemistry is a valuable tool for the identification and visualization of tissue antigens in biological research and clinical diagnostics. Source: ScienceDirect
Test UseValue
proposition
Idylla™ Hematology Assay
Detection of mutations in samples from patients with certain hematological cancers
Fast time-to-result vs current batch-based methods, ease-of-use, standardization
PredictivePrognosticDiagnostic
Idylla™ EGFR/BRAF+ Mutation Test
Detection of mutations in samples from patients with brain cancer
Ease-of-use, sample versatility, fast time-to-result
Idylla™ Brain Assay
Detection of mutations in samples from patients with endometrial cancer
Ease-of-use, sample versatility, fast time-to-result, cost-effectiveness
Idylla™ Endometrium Assay
Detection of mutations in FFPE samples from patients with advanced breast cancer
Fast time-to-result, ease-of-use, sample versatility
Idylla™ ABC Panel Collaboration with
Idylla™ Pan-tumor MSI Test
Detection of the vast majority of actionable gene fusions in FFPE samples from patients with NSCLC, including a.o. ALK, ROS1, RET, METex14 and NTRK1-3
Fast time-to-result, ease-of-use, sample versatility
Idylla™ GeneFusion Assay
22
1st generation Idylla™ products: PERFORMANCE & VERSATILITY
Establish Idylla™ as the most versatile MDx testing platform
Superior ease-of-usewith <2 min hands-on time
Fast turn-around-timedelivering 10 days faster
Broad sample versatilitygives results on 80% of samples that failed on NGS
Superior performancewith >95 % concordanceand <2 % invalids
Purpose Technology Applications
All basic building blocks for sample preparation, qPCR(DNA/RNA) and melting curveanalysis are available
Solid biopsies (e.g. FFPE, cytological samples)
Liquid biopsies (e.g. plasma, urine)
Pathogens (e.g. swabs, viral transport medium)
Sepsis (e.g. blood)
• Expanding Idylla™ menu
• Growing number of Idylla™ partnerships
FFPE = formalin fixed, parrafin embedded
23
2nd generation Idylla™ products: FASTER & CHEAPER DEVELOPMENT
Idylla™ FLEX technology (in development), a new revolution under the hood of Idylla™
• Mass manufactured Idylla™ FLEX cartridges that can be used acrossmultiple panels
• Panel-specific Idylla™ FLEX reagents for off-line customization of the cartridge
• Reagent and software design based on proprietary Artificial Intelligence algorithms
Purpose Technology Applications
Develop more Idylla™ productsfaster, at a lower cost
• Eliminate in-line cartridge customization, to reduce development lead times and cost
• Industrialize and accelerate thedesign of reagents and software for new panels
• Enable efficient customization of the Idylla™ cartridge
Improved development lead times, cost and scalabilityenables:
• Acceleration of Idylla™ menu growth
• Further expansion into currently unserved oncology markets
• Customized Idylla™ panels
Biocartis designs the Idylla™ FLEX reagents
User defines the Idylla™ panel
3. User inserts cartridge into Idylla™ instrument
1. User adds Idylla™ FLEX reagents and
sample …
4. User retrieves results with fast TAT
2. … into the Idylla™ FLEX cartridge
24
STEP 1Design of new panels
STEP 2Routine use
The IdyllaTM FLEX technology complements the core strengths of Idylla™ (ease-of-use, speed, performance and sample versatility)
with off-line customization
25
1. Marketed by Roche. 2 Marketed by AstraZeneca. 3. Marketed by Merck KGaA and Eli Lilly. 4. Marketed by Amgen. 5. Marketed by Bayer (licensed from Eli Lilly’s Loxo). 6. Marketed by Merck. 7. Marketed by Roche
• MDx tests detecting specific tumor mutations used for therapy selection in a specific cancer type
• Significant pharma pipeline of new targeted therapies
• Exampleso Zelboraf®1 (BRAF)o Tagrisso®2 (EGFR)o Erbitux®3 (RAS)o Vectibix®4 (RAS)
• Pan-tumor application of tumor mutation tests for therapies selected based on genetics rather than location of the tumor
• Allows therapy use across multiple cancer types
• Positive impact on underlying test volumes
• Exampleso Vitrakvi®5
o Keytruda®6
o Rozlytrek®7
• MDx tests based on RNA Gene Signatures are used for e.g.:o Diagnosiso Prognosis
• Often high value once validated & clinical value demonstrated
• Exampleso SeptiCyte® RAPIDo ThyroidPrint®
• MDx tests supporting immuno-oncology cancer treatments
• Consists of many different therapies, e.g.:o Immune checkpoint
inhibitorso Cell and viral therapieso Vaccines
• High unmet need for underlying MDx testing
• MDx tests via liquid samples
• Use in diagnosis, prognosis and Molecular Surveillance (i.e. therapy selection, response and recurrence monitoring)
• Can be done through off-the-shelf catalogue panels as well as tumor-informed, personalized panels
Diagnosis Treatment start Treatment stop
MOLECULAR SURVEILLANCE
Prognosis & therapy selectionScreening & diagnosis
Response monitoring Recurrence monitoring
Gene signatures Targeted therapy Pan-tumor Immuno-oncology Liquid biopsy
1
2
Background collaboration About thyroid testing
1 S. Vargas-Salas et al., Genetic testing for indeterminate thyroid cytology: review and meta-analysis, 2018, Endocrine-Related Cancer, https://erc.bioscientifica.com/; 2 Demonstrating that ThyroidPrint® performs in the same manner in populations with different ethnicities and genetic backgrounds (M. Zafereo et al., A Thyroid Genetic Classifier Correctly predicts benign nodules with indeterminate cytology: two independent multicenter, prospective validation trials); 3 Results are expected end of October 2021; 4 FNA = fine needle aspirate. In FNA biopsy procedures, approximately 350,000 of which are performed annually in the US alone (Popoveniuc G, Jonklaas J. Thyroid nodules. Med Clin North Am. 2012;96(2):329-349. doi:10.1016/j.mcna.2012.02.002), cells are collected from the thyroid nodule for microscopic examination; 5 Faquin WC, Bongiovanni M, Sadow PM 2011 Update in thyroid fine needle aspiration. Endocrine pathology 22:178‐183.; 6 To determine the true nature of the nodule as standard practice. Haugen BRM, Alexander EK, Bible KC, Doherty G, Mandel SJ, Nikiforov YE, Pacini F, Randolph G, Sawka A, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward D, Tuttle RMM, Wartofsky L 2015 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid: official journal of the American Thyroid Association; 7 Quantitative Reverse Transcription PCR. PCR or Polymerase chain reaction is an efficient and cost-effective way to copy (amplify) small segments of DNA or RNA. As such, millions of copies of a section of DNA are made in just a few hours, allowing further analysis for clinicians to diagnose and monitor diseases using a minimal amount of sample, such as blood or tissue. Source: www.genome.gov, last consulted on 22 October 2020; 8 This means that the probability of the nodule being malignant drops from 25% to less than 5%, allowing follow-up to be recommended as an alternative to surgery. Info and source: https://thyroidprint.com/en/home-us/, last consulted on 22 October 2020; 9 NPV (Negative Predictive Value) > 95%
Background GeneproDx
• A molecular diagnostics company based in Santiago, Chile
• ThyroidPrint was clinically validated in a multicenter trial in Chile, after which it was launched in Latin America1 in Sept 2018, and in a second independent multicenter, prospective trial in the US in Dec 20192
• New international validation study ongoing3 in leading academic sites in Europe, the US and Latin-America
• Thyroid nodules are very common, often detected during routine medical exam or by patient self-assessment
• Only ca. 10% of FNA biopsy procedures4 reveal malignant cells; approx. 70% confirm a benign diagnosis. The remaining 20% are indeterminate, meaning no certain diagnosis can be provided to physician and patients5
• Annually, > 1.2 million thyroid cytology evaluations are reported as indeterminate1. Here, diagnostic surgery of the thyroid gland is frequently recommended6
• Risk of malignancy in these indeterminate cases is est. between 15-35%, meaning that surgical intervention is unnecessary in up to 65-85%6
• A qRT-PCR based mRNA-expression classifier7 test that helps determine if a thyroid nodule with indeterminate cytology result is benign or malignant8
• Benign test result9 allows physicians to recommend watchful waiting as an alternative to diagnostic surgery
• This prevents exposing patients to surgical risks & permanent thyroid hormone supplementation, and significantly reduces health costs due to unnecessary surgery1
About ThyroidPrint®
26
• A license, development and commercialization agreement focused on the development of GeneproDx’s novel genomic test ThyroidPrint® on the Idylla™ platform
• GeneproDx will take the lead in the development of the Idylla™ ThyroidPrint® test
• Biocartis will be responsible for the distribution of the ThyroidPrint® on Idylla™ through its growing global commercial infrastructure of Idylla™ instruments
TARGETED THERAPIES
Short-term
IMMUNO-THERAPY
Bio
cart
is o
wned t
est
s
• 2-cartridge menus for CRC and lung
• Pan-cancer applications
• Additional cancer types
• MSI • Hot-Cold signatures• Resistance testing
MONITORING
• Therapy response & MRD5
• Recurrence monitoring
Mid-term Long-term
• Establish breast franchise
• Urology • New cancer types & customer segments
Part
ner
ow
ned
PROPRIETARY GENOMIC SIGNATURES
• Cell therapy management
Indicative, subject to change
+ Depicts annual long term addressable Idylla™ cartridge volume potential. Based on management estimates. Focused on Europe, US and Japan (excluding China and RoW). For indicative purposes only. 1. Based on incidence / prevalence, potential eligibility (e.g., according to tumor stage and treatment) and # tests / patient. 2. Based on incidence and current / potential guideline testing eligibility for cancer types where immune checkpoint inhibitors and cell therapies are most relevant. 3. Based on incidence and current / anticipated cancer guidelines for colorectal, lung, and skin cancer. 4. Based on current partner content collaborations and addition of new content that could benefit from Idylla™ dependent on partnerships. 5. MRD = Minimal Residual Disease
10m to 15m+1
4m to 5m+2
3m to 4m+3
1m to 5m+4
ANNUAL VOLUME POTENTIAL
27
28
• The current Idylla™ testing offering addresses
approx. 4m annual testing volume
• The new Idylla™ pipeline allows to grow to a
total addressable market of over 10m annual testing volume
• High growth areas thanks to the combination of unique Idylla™ characteristics:
• Fast time-to-result• Ease-of-use• Highly accurate• Sample versatility• Cost-effectiveness versus existing methods• Suitable technology for monitoring
4,1
10,1
6,0
Current Idylla™ offering Pipeline Future Idylla™ offering
Total addressable market volumes (in millions)1 Unique Idylla™ USPs for rapid oncology Dx
1 Total addressable market includes Europe, the US and RoW (including Japan, excluding China)2 Current Idylla™ offering includes Idylla™ assays in Melanoma (BRAF), Colorectal (KRAS, NRAS, BRAF and MSI) and Lung (EGFR)3 Pipeline includes assays in Lung (GeneFusion), Breast (Idylla™ ABC Panel), Pan cancer (MSI), Thyroid (ThyroidPrint® on Idylla™), Endometrium, Hematology and Brain4 Future Idylla™ offering excludes surveillance monitoring
2 3 4
1. COVID-19 3. FUTURE POTENTIAL
• Responsible for est. 8m deaths/year globally3, est. annual hospital expense of > USD 24b in the US alone4
• High unmet need: current markers are not rapid (blood cultures) or are non-specific (PCT, CRP)5; increased risk in pandemic times
• Fast clinical decisions impact patients outcome
• Relevant Idylla™ tests:
• SeptiCyte® RAPID on Idylla™6 (partnershipImmunexpress)
• Idylla™ EndPoint test (partnership EndPoint Health): aims at enabling biomarker-based therapeutic decisions in patients with critical illnesses7, such as sepsis
• Pandemic-related testing: temporary high need for decentralized MDx testing, faster installed base building in acute settings
• Support Intensive Care Unit (ICU)2 positioning,together with SeptiCyte® RAPID on Idylla™6
• Idylla™ tests:
• Launch Idylla™ SARS-CoV-2 Test2 (CE-IVD,EUA pending) with good performance &positive early field feedback
• Current development of Idylla™ SARS-CoV-2/Flu/RSV Panel: ability to support flu season testing
• Partnership COVID-19 IndustryConsortium: accelerate and improve COVID-19testing across the globe1
29 1 On 1 October 2020, Biocartis announced to have joined the COVID-19 Testing Industry Consortium of nineteen Healthcare Community Organizations led by Bristol-Myers Squibb (BMS). More info here; 2 The Idylla™ SARS-CoV-2 Test and the SeptiCyte® RAPID (CE-IVD) test on Idylla™ are intended for use in microbiology labs; 3 Global Sepsis Alliance, www.sepsis.org; 4Paoli et al. Crit Care Med (2018): 46: 1889-1897; 5 PCT = Procalcitonin (PCT) assay is a biomarker for systemic inflammation; CRP = C-reactive protein, a biomarker for systemic inflammation. Positive bacteriological cultures, including blood cultures, may not be available before 24 to 48 hours; interpretation of local colonization may be ambiguous; and traditional markers ofinfection, such as body temperature and white blood cell (WBC) count, may not be specific ; 6 SeptiCyte® RAPID is a host-response test that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis; 7 The Idylla™ Endpoint test is intended to be a PCR based mRNA-expression classifier test that aims at enabling biomarker-basedtherapeutic decisions in patients with critical illnesses. More specifically, the test will be intended to help identify patients with critical illnesses that are likely to benefit from corticosteroid therapy versus patients in which such therapy should be avoided
2. SEPSIS
• Syndromic panel testing:
• One of fastest growing MDx segments
• Idylla™’s unique multiplexing platformcapabilities allow entry into thismarket
LONG TERM STRATEGY: Easy & rapid Idylla™ infectious disease testing to support the patient journey in the intensive care unit (ICU),
including rapid triage and therapy selection of critically ill patients
30
1 Announced on 26 March 2020. Developed in collaboration with Immunexpress. More info here; 2 Host-response based tests focus on measuring biomarkers that are indicative of the response of a patient’s immune system to an infection rather that measuring pathogens that are the cause of the infection. Moreover, SeptiCyte® RAPID not only discriminates sepsis from SIRS but also correlates with viral sepsis infection, versus procalcitonin (PCT) which increases with severity of bacterial but not viral infection and is also a non-specific marker of inflammation; 3 Distribution of the Idylla™ SARS-CoV-2 Test was initiated in the US in Q3 2020 per US FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), May 2020, Section IV.C. Commercial Manufacturer Development and Distribution of Diagnostic Tests Prior to EUA Submission; 4 The Idylla™ SARS-CoV-2 Test and the SeptiCyte® RAPID (CE-IVD) Test on Idylla™ are intended for use in microbiology labs; 5 Zhou et al., Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study, published online 9 March 2020, https://doi.org/10.1016/S0140-6736(20)30566-3; 6 Sepsis developed at a median of 9 days (7–13) after illness onset among all patients, followed by ARDS (12 days [8–15]), acute cardiac injury (15 days [10–17]), acute kidney injury (15 days [13–19.5]), and secondary infection (17 days [13–9])
Idylla™ SARS-CoV-2 Test (CE-IVD)
• Agreement with Immunexpress expanded1 in H1 2020• A rapid, host-response2 test that distinguishes sepsis from non-
infectious SIRS (systemic inflammatory response syndrome), expected to provide actionable results in about one hour
• Biocartis will lead commercialization in Europe as exclusive distributor of SeptiCyte® RAPID (CE-IVD), Immunexpress will lead commercialization in US
• Successful release CE-IVD marked version on 6 October 2020
SeptiCyte® RAPID on Idylla™ (CE-IVD)
• Intended to detect SARS-CoV-2, the virus that causes COVID-19, from nasopharyngeal swabs in viral transport medium
• Successfull EU market release as CE-IVD on 10 November 2020• Emergency Use Authorization (‘EUA’) with US FDA is pending but
distribution continues per notification criteria in the US FDA's COVID-19 Policy3
• Successful release CE-IVD marked version on 10 November 2020
Unique combined offering for ICUs4 as recent data5 indicate that sepsis is the most frequently observed complication in COVID-196
Background collaboration About critical illness
1 A life-threatening condition resulting from fluid building up in the lungs of a patient, which restricts oxygen take-up and depriving organs of the oxygen they need to function; 2 The Lancet, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32989-7/fulltext, last consulted on 29 October 2020; 3 Paoli et al. Crit Care Med (2018): 46: 1889-1897 and https://journals.lww.com/ccmjournal/Fulltext/2020/03000/Sepsis_Among_Medicare_Beneficiaries__3__The.4.aspx, last consulted on 29 October 2020 ; 4 NCBI, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4968574/n, last consulted on 29 October 2020; 5 Submitted for Emergency Use Authorization (EUA) with the US FDA on 10 August 2020; 6 The SeptiCyte® RAPID on Idylla™ (CE-IVD) was developed in collaboration with Immunexpress. The test is a host-response test that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about one hour. Available to select countries within the EU and European region. Check availability with your local Biocartis representative. More info on the Biocartis website
Background Endpoint Health
• A Palo Alto, CA (USA) based company developing personalized care solutions and targeted therapies for critically ill patients
• On 28 September 2020, Endpoint Health announced a partnership to create the world’s first precision medicine clinical trial network focused on critical illness
• Idylla™ Endpoint Test intended to be used in the network’s first interventional trial
• Critical illnesses such as sepsis and Acute Respiratory Distress Syndrome (ARDS)1 are life-threatening conditions often characterized by dysregulated immune response to infection
• Globally, sepsis alone is associated with 11m deaths annually2, is one of the most expensive health conditions with annual healthcare costs est. at > USD 60bn in the US alone3
• Long recognized need for more targeted approach to therapy developmentand patient care 4
• Rapid companion diagnostic test aimed at enabling targeted therapies and personalized care approaches in critical illness
• In addition to Biocartis’ current infectious disease tests, the Idylla™ SARS-CoV-2 Test5 and the SeptiCyte® RAPID6 on Idylla™, the Idylla™ Endpoint test is expected to guide the safe and effective use of novel therapies and improve routine care choices in critically ill patients
About the Idylla™ Endpoint test
31
• Endpoint Health (EPH) will lead the development & registration of the Idylla™ Endpoint test in interventional trials across a range of interventions incl. targeted immunotherapy & coagulation therapy indications
• Parties intend to collaborate on the commercialization of the test, building on growing worldwide commercial infrastructure of Idylla™ instruments
• Partnership highlights the unique rapid, highly accurate and easy-to-use features of Idylla™ in areas outside of oncology
SeptiCyte® PLUS on Idylla™
32
Idylla™ SARS-CoV-2 Panel (in development)Idylla™ Syndromic Panel
(> 20-30 pathogens multiplexed)
Idylla™ SARS-CoV-2 Test
SeptiCyte® RAPID on Idylla™
Idylla™ Endpoint test
Does the patient have an infection? Yes/No
Does the patient have a viral/bacterial infection?
Does the patient have a SARS-CoV-2 infection?Yes/No Which respiratory pathogen is
causing the symptoms?
Which supportive therapy should the patient receive?• Corticosteroids• Immuno-stimulants• Anti-coagulants
Target population
Idylla™ menu
Person at riskSymptomatic
patientCritically ill patient Confirmed patient
To develop
With viral/bacterial differentiation
ICU = Intensive Care Unit
SeptiCyte® RAPID on Idylla™
Idylla™ SARS-CoV-2 Test
Idylla™ SARS-CoV-2/Flu/RSV Panel
Idylla™ Endpoint test
Syndromic panels
33
Cartridge Development USACE Japan China
EUA pending
Regulatoryprocess ongoing
Ongoing
Ongoing
= planned start
Legend
RUO = Research Use Only, not for use in diagnostic procedures; CE = CE-marked IVD; EUA = Emergency Use Authorization. Source: US FDA website. The Idylla™ development pipeline reflects the different cartridges and biomarkers in development, including cartridges that can be used for research applications. Please see here for more information about the respective studies, or to the specific product labeling for applicable intended use for each individual Biocartis product. Overview is subject to change in amongst others prioritization of test development by Biocartis and/or partners driven by commercial, partnering & operational considerations.
Ongoing
Pandemic menu
Pandemic menu
Commercialization through direct sales force
Commercialization through distribution partners
Commercialization through joint venture
Over 70 countries covered through four sales channels:
Direct sales force covering Western European countries, US and Canada
Distributor contracts in place covering ~ 65 countries. Distribution agreement with Nichirei Biosciences for Japanese market
Joint venture in China with Wondfo
Pharma collaborations (e.g. Merck KGaA (Darmstadt, Germany), Amgen, AstraZeneca, BMS and Kite/Gilead) and content partnerships (e.g. Immunexpress, GeneproDx, Endpoint Health)
1
2
3
1 Situation as per 31 December 201934
4
Second cartridge manufacturing line ‘ML2’: facts & figures
• Located in Mechelen (BE), additional annual capacity of+ 1,000,000 cartridges
• Fully automated assembly workstations (vs semi-automated on 1st line, annual capacity +200k cartridges)
• Plastic parts with new multi-cavity molds (vs single cavity on 1st line)
• To support volume growth & cost effectiveness
35
• Successful transfer Idylla™ NRAS-BRAF Mutation Test (CE-IVD) and Idylla™ MSI Test (CE-IVD) to second manufacturing line ‘ML2’ during H1 20201
• 3 out 4 of highest volume assays now produced on ML2: major step in lowering manufacturing cost
• Transfer Idylla™ EGFR Mutation Test (CE-IVD) ongoing
• Idylla™ SARS-CoV-2 Panel (in development) expected on ML2 in 2021
H1 2020 manufacturing milestones
1 The Idylla™ KRAS Mutation Test (CE-IVD) was transferred to ML2 in 2019
Installed base x
Instrument utilization x
Average selling price = Sales
Key drivers• Commercial footprint• Commercialization
partnerships
Key drivers• Menu of tests• Regulatory approvals
Key drivers• Reimbursement• Competitive advantage Gross margin driven by
• Volume• Manufacturing
automation
36
• 25 February 2021 2020 full year results
• 1 April 2021 Publication 2020 annual report
• 22 April 2021 Q1 2021 Business Update
• 14 May 2021 AGM Biocartis Group NV
• 2 September 2021 H1 2021 results
• 10 November 2021 Q3 2021 Business Update
37
Shareholder overview (as per 24 November 2020) Coverage
Note: The percentages above are based on the most recent transparency notifications received by Biocartis. The Biocartis investor website for more details.
Listing: Euronext BrusselsISIN: BE0974281132 Ticker: BCART
Stock facts
Michael Healy
Dylan van Haaften
Thomas Guillot
Lenny Van Steenhuyse
Alexandru Cogut
Maja Pataki
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Shareholder >3% table # shares % shares
Invesco, Ltd. 6,969,077 12.4%
Johnson & Johnson Innovation 5,481,128 9.7%
ParticipatieMaatschappij Vlaanderen NV (Flemish Region) 2,342,345 4.2%
Other institutional and retail investors 41,589,538 73.8%
Total outstanding shares (non-diluted) 56,382,088 100.0%
Appendix 1: H1 financials
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Additional details (in EUR 1,000)
Product sales revenue H1 2020 H1 2019
Idylla™ system sales 1,837 2,499
Idylla™ cartridge sales 9,584 7,481
Product sales revenue 11,421 9,980
Collaboration revenue H1 2020 H1 2019
R&D services 4,623 4,350
License fees 123 2,467
Milestones 0 0
Collaboration revenue 4,746 6,816
Breakdown total operating income
In EUR 1,000 H1 2020 H1 2019
Product sales revenue 11,421 9,980
Collaboration revenue 4,746 6,816
Service revenue 530 351
Total revenue 16,697 17,147
Grants and other income 909 151
Total operating income 17,606 17,298
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Condensed income statement
In EUR 1,000 H1 2020 H1 2019
Total operating income 17,606 17,298
Cost of goods sold (9,233) (8,742)
R&D expenses (20,303) (20,031)
S&M expenses (7,931) (8,811)
G&A expenses (6,491) (6,399)
Total operating expenses (43,958) (43,983)
Operating result (26,352) (26,685)
Net financial result (5,129) (2,822)
Share in results of associates (195) 181
Income taxes 118 18
Net result (31,558) (29,670)
Comments
• Total operating income of EUR 17.1m, level with H1 2019:o Commercial cartridge sales up EUR 1.4m or +28% vs H1
2019 on the back of 12% higher volumes and increasing ASPo System sales decrease by EUR 0.7m
o COVID-19 restricted customer prospection mainly in US and RoW and slowed down new instrument placements
o Higher proportion of reagent rental o Collaboration revenues affected by project delays
• COGS increase of EUR 0.5m driven by higher commercial product sales
• Gross margin on product sales of 19%, compared to 12% in H1 2019
• Operating expenses of EUR 44m remain stable
• Net financial result increase entirely driven by the convertible bond:o EUR 3.3m interest on the convertible bond;o EUR 2.2m non-cash debt appreciation of the Company’s
convertible bond
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Condensed cash flow statement Remarks
1. Excludes the effect of exchange rate differences on the cash balances held in foreign currencies2. Including EUR 1.2m of restricted cash in H1 2020 and H1 2019
In EUR 1,000 H1 2020 H1 2019
Result for the period (31,558) (29,670)
Depreciation and amortization 5,010 3,713
Impairment losses 721 202
Working capital changes (20,938) (26,515)
Taxes & interests paid (3,582) (1,486)
CF operating activities (24,526) (28,357)
CF investing activities (1,028) (5,267)
CF financing activities (3,456) (179,465)
Total net cash flow1 (29,010) 145,841
Cash and cash equivalents2 149,674 209,200
Financial debt 165,259 166,578
• The net cash outflow from operating and investing activities amounted to EUR 25.6m in H1 2020 compared to EUR 33.6m in H1 2019:
o A lower investment in net working capital resulting from the collection of a tax credit
o A lower capital expenditure resulting from a lower number of Idylla™ instruments placed under reagent rental agreements.
• Net cash flow of EUR 29.0m, resulting in a cash position of EUR 150m as per end H1 2020, in line with expectations
Appendix 2: other
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LifeArc
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AstraZeneca
1 FFPE = Formalin Fixed, Paraffin Embedded; 2 CDx = companion diagnostics; 3 RUO = Research Use Only, not for use in diagnostic procedures
• Expansion partnership announced 22 January 2020
• Collaborative development & commercialization of Idylla™ tests to support AstraZeneca’s pharma products, such as CDx2 development projects
• Expansion focused on:o Ongoing European prospective study Idylla™ EGFR
Mutation Test extended to additional countries in- & outside Europe
o New: study if liquid biopsy testing using the Idylla™ ctEGFR Mutation Assay (RUO3) could provide further benefits to tissue-based EGFR testing
• Expansion partnership announced 1 September 2020
• Ongoing co-development of Idylla™ ABC Panel, targeting multi-gene panel of predictive & resistance-inducing mutations based on a FFPE1 sample (breast cancer)
• Under new agreement: LifeArc obtains non-exclusive licenceto use Idylla™ platform for development of Idylla™ assays in infectious & immune related diseases
• Aimed at supporting patient stratification & treatment monitoring of patients with a.o. bacterial, fungal & viral infections
BMS
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• Agreement1 focused on MSI testing in connection with IO therapies2
• Allows for joint developments & registrations of Idylla™ MSI Test for use in a variety of indications, commercial settings & geographies
• Two ongoing projects:
* The title of the slide ‘immuno-oncology/liquid biopsy’ refers to one of the strategic pillars of Biocartis’ strategy. We refer to the specific product labeling for applicable intended use for each individual Biocartis product.1 The agreement with Bristol-Myers Squibb Company (NYSE: BMY), a global biopharmaceutical company, was announced on 12 March 2019; 2 OPDIVO® (nivolumab) plus low-dose Yervoy (ipilimumab) is the first immuno-oncology combination treatment approved by US FDA for MSI-High or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with certain chemotherapies. Treatment with fluoropyrimidine, oxaliplatin and irinotecan. Note that OPDIVO® is also approved in the US as as a single agent, for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. OPDIVO® generated USD 7.2m of global revenues in 2019 (Source: https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-reports-fourth-quarter-and-full-year-fi-1, last consulted on 3 March 2020); 3 Kite’s Yescarta™ (Axicabtagene Ciloleucel) was the first CAR-T therapy approved by the US FDA for treatment of adult patients with relapsed or refractory large B-cell lymphoma. Biocartis announced its partnership with Kite/Gilead on 1 June 2019
Kite/Gilead
• Master development & commercialization agreement aimed at development of assays on Idylla™ supportive to Kite’s therapies3
• Speed & ease-of-use of Idylla™ could enable regular, rapid monitoring of patients under cell therapies in a near-patient setting, which is expected to help optimize patient management
• Cell & checkpoint blockade therapies are expected to cover awide range of complementary indications in solid & hematological tumors, and may be used depending on the tumor’s immune activity status
• Registration in the United States of theIdylla™ MSI test as a CDx test in mCRC
• Registration of the Idylla™ MSI test as a CDxtest in mCRC in the People’s Republic of China
• Virtually 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
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Step 1: tissue macroscopy Step 2: formalin-fixing Step 3: paraffin-embedding Step 4: microtome cutting
A laboratory technician cuts the tissue into smaller pieces
This incubates overnight in formalin for optimal conservation while maintaining the fixation of the morphology
The next day, the tissue is embedded in fluid paraffin
The paraffin block is then cut into thin slices (tissue sections), suitable for (microscopic) analysis
FFPE is the gold standard sample type within oncology
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Biocartis Investor RelationsGeneraal de Wittelaan 11 B
2800 Mechelen
BELGIUM
tel. +32 15 63 17 29
www.biocartis.com
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