Download - Biocartis Corporate presentation
2
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 basisof, 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 thebasis 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, speaks as of today, and is subject to updating, completion,revision and amendment and such information may change materially from time to time. No person is under any obligation to update or keep current the information containedin 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 thefairness, accuracy, reasonableness or completeness of the information contained herein. Neither the Company nor any other person accepts any liability for any loss howsoeverarising, 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'sresults, 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 ofthe 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 thatforward-looking statements are not guarantees of future performance and that its actual results and condition and the development of the industry in which the Companyoperates 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 expresslydisclaim 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 theCompany's expectations or any change in events, conditions or circumstances on which these forward-looking statements are based, except as required by applicable law orregulation.
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 citizenor 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 whichwould require any registration or licensing within such jurisdiction. The distribution of this document in certain jurisdictions may be restricted by law and persons into whosepossession 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.
31 Guangzhou Wondfo Biotech Co., Ltd. (‘Wondfo’, SHE: 300482) is a fast growing diagnostics leader in China; 2 Defined as the world excluding European direct markets, US, China and Japan
Differentiated technology
Unique Idylla™technology in oncology, expanding in infectious
diseases
Attractive markets
Worldwide commercial footprint
Very strong performance in H1 2021
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 & additional product registrations (incl. US FDA filings) & menu partnerships
• Ongoing geographical expansion (penetration in US market, initiation of commercialization in China & Japan)
• Production of all key oncology assays transferred to the highly automated second cartridge manufacturing line driving cost optimization
• 2021 outlook 40% cartridge growth still in reach: successful mitigation of fire incident, but still subject to full restart ML2 line by 2nd half September & timely availability of reagent raw materials for cartridges
• Cartridge manufacturing: new concept for simplified, cost-efficient cartridge manufacturing under evaluation
• Unique platform features bring strong competitive advantage in oncology testing, broad test menu (solid & liquid biopsies) currently focused on targeted therapies &immunotherapy, gene signatures, move into monitoring
• Validation via oncology (e.g. Amgen, Merck KGaA, AstraZeneca, Bristol-Myers Squibb, Kite/Gilead, GeneproDx, SkylineDx) and infectious disease partners (Immunexpress, Endpoint Health)
• Expansion of pandemic response test menu post H1 2021 with CE-IVD launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel• Innovating the Idylla™ technology for customization of assays and new concept for simplified, cost-efficient cartridge manufacturing
• Direct sales approach in Western Europe, Canada and US
• First oncology assay US FDA submission in April 2021: Idylla™ MSI Test 510(k) US FDA notification
• Strategic partnerships established for China & Japan: joint venture with Wondfo1 (China) and commercial collaboration with Nichirei Bio (Japan)
• Distributor markets3 model: partnerships with local distribution partners for relevant distributor MDx markets supported by Biocartis distributor markets sales team
• 156k commercial Idylla™ cartridges sold in H1 2021, almost twice as high as in H1 2020 (+96%);• Robust growth in oncology in all regions; solid contribution from infectious diseases, comparable to H2 2020 volumes against backdrop of declining global COVID-19 testing
volumes• 189 new Idylla™ placements in H1 2021 (101 in H1 2020) mainly driven by demand in EU and distributor2 markets as well as by content partners• Installed base of 1,770 Idylla™ instruments end of H1 2021• Expanded (AstraZeneca) and new partnerships in oncology (SkylineDx) during H1 2021
• 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) in oncology and infectious diseases• Proven market access & expanding into infectious disease market: pandemic test menu based on COVID-19 and sepsis testing to support patient journey in
intensive care unit (ICU), longer term developments based on unique multiplexing capabilities of Idylla™ (syndromic panels)
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
• 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 time6
7
Only selected studies shown on slide
1 Arcila ME, Yang S-R, Momeni A, Mata DA, Salazar P, Chan R, Elezovic D, Benayed R, Zehir A, Buonocore DJ, Rekhtman N, Lin O, Ladanyi M, Nafa K, Ultra-Rapid EGFR Mutation Screening Followed by Comprehensive Next-Generation Sequencing: A Feasible, Informative Approach for Lung Carcinoma Cytology Specimens with a High Success Rate., JTO Clinical and Research Reports (2020), doi: https://doi.org/10.1016/j.jtocrr.2020.100077., available online 18 July 2020; Arcila ME et al., Rapid EGFR Mutation Detection Using the Single-Institution Experience of 1200 Cases Analyzed by an In-House Developed Pipeline and Comparison with Concurrent Next-Generation Sequencing Results Idylla Platform, J Mol Diagn 2020, Published on 23 December 2020, 1-12; https://doi.org/10.1016/j.jmoldx.2020.11.009; 2 RUO = Research Use Only, not for use in diagnostic procedures; 3 Next Generation Sequencing; 4 Behera et al. Circulating tumor DNA mutation as a prognostic marker in melanoma with brain metastasis. J Clin Oncol 39, 2021 (suppl 15; abstr e21560); 4 Only the abstracts at the virtual AMP Europe congress (Association for Molecular Pathology, virtual congress taking place 14-18 June 2021) and ASCO (American Society of Clinical Oncology) in the US were screened
• One abstract4 presented at the ASCO (American Society of Clinical Oncology) Annual Meeting (4-8 June 2021)
• One abstract on the SeptiCyte© RAPID on Idylla™ presented at the 31st ECCMID(European Congress of Clinical Microbiology & Infectious Diseases) congress (9-12 July 2021)
• Studies included the publication of two studies1 by Memorial Sloan KetteringCancer Center (‘MSKCC’, New York, US)
• Concluding that Idylla™ EGFR testing (RUO2)
• Enables rapid assessment of the most common EGFR mutations with lowsample input, even on different sample types, without compromisingsubsequent more comprehensive NGS3 testing
• Can be useful in cases where EGFR mutation results were negative and further testing is needed
Two studies on rapidEGFR Idylla™ testing
ASCO and ECCMID
H1 2021 publication highlights
8
Expansion into infectious diseases
• Diversifying the Idylla™ test menu to accelerate further installed base growth, focus on rapid response testing for critical illness
• First expansions in infectious diseases:
• Pandemic menu: Idylla™ SARS-CoV-2 Test, SeptiCyte® RAPID and recent CE-IVD launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel
• Idylla™ Endpoint Test (in development)
• Growing partner business model to accelerate core strategy
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 through five strategic areas where Idylla™ can make a difference in the cancer treatment continuum:
1. Gene signatures2. Targeted therapy3. Pan-tumor4. Immuno-oncology5. Liquid biopsy
The SeptiCyte® RAPID on Idylla™ is in collaboration with Immunepress. The Idylla™ Endpoint Test is in collaboration with Endpoint Health.
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, SkylineDx)
1
2
3
1 Situation as per 31 December 20209
4
10
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
11
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
KRAS
NRAS-BRAF
ctKRAS
ctNRAS-BRAF
MSI
12
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. An IVD-version of the Idylla™ GeneFusion Panel (IVD) is 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 Merlin Assay on the Idylla™ platform is a collaboration with SkylineDx. The ThyroidPrint Assay on the Idylla™ platform is a collaboration with GeneproDx. Development of Idylla™ EGFR-BRAF+ Mutation Assay suspended awaiting completion of the new simplified, cost-efficient cartridge concept. Timelines will be communicated at a later stage. 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.
EGFR
ctEGFR
BRAF
KRAS
GeneFusion
EGFR/BRAF+
BRAF
ctBRAF
NRAS-BRAF
Merlin Assay on Idylla™ (SkylineDx)
Idylla™ ABC Assay (LifeArc)
PMA
CE Japan
PMA
China
510(k) submitted Ongoing
Ongoing
Ongoing
Ongoing
Ongoing
KRAS (pancreatic cyst fluid samples)NRAS & BRAF (thyroid FNA samples) MSI (pan-tumor)
IO: MSI
IO: Cell therapy monitoring
ThyroidPrint® on Idylla™ (GeneProDx)
Endometrium
Hematology
Brain
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
Legend
= on market
Ongoing
Ongoing
Ongoing
Ongoing
Product update ongoing
PMA Ongoing Ongoing
131 CDx = Companion Diagnostics = A CDx test is a test used as a companion to a therapeutic drug, that helps predict if a patient is likely to respond to a treatment or not; 2 mCRC = Metastatic colorectal cancer; 3 VLAIO = The Flanders Organization for Innovation & Entrepreneurship. The grant is intended tosupport the development of the GeneFusion Assay on the Idylla™ platform, and to support related research studies on different sample and tumor tissue types, including on lung cancer tissue. The Idylla™ GeneFusion Assay will include a highly multiplexed panel of established and emerging biomarkers, and willbe the first FFPE (Formalin fixed, paraffin embedded ) RNA based assay (= RNA or Ribonucleic Acid is one of the three major biological macromolecules that are essential for all known forms of life along with DNA and proteins) on the Idylla™ platform. The Idylla™ GeneFusion Assay is expected to bring results
in approx. 3 hours, with less than 2 minutes hands-on time; 4 GeneproDx is a molecular diagnostics company based in Santiago, Chile; 5 A sentinel lymph node biopsy (SLNB) is a surgical procedure used to determine whether cancer has spread beyond a primary tumor into the lymphatic system. Source: MayoClinic, https://www.mayoclinic.org/tests-procedures/sentinel-node-biopsy/about/pac-20385264, last consulted on 21 April 2021
Partnership AstraZeneca
• Announced 22 January 2020• Master collaboration agreement aimed at rapid & easy
testing in lung cancer• Expansion of partnership to, amongst others, the area of
liquid biopsy testing using the Idylla™ ctEGFR Mutation
Assay
Partnership BMS China
• Announced 5 March 2020• Biocartis announced the expansion of its partnership with
Bristol-Myers Squibb Company, to now also pursue, after theUS, the registration of the Idylla™ MSI test as a CDx1 test in
mCRC2 in China
SkylineDx
• Announced 22 April 2021• Development by SkylineDx of its novel Merlin Assay on Idylla™• Assay aims at predicting a patient’s risk of nodal metastasis in
melanoma, identifying patients who may safely forgo an SLNbiopsy5
• Biocartis will lead commercialization in Europe through itsgrowing Idylla™ network
1 2
4GeneproDx
• Announced 3 November 2020• License, development & commercialization agreement with
GeneproDx4 for development of the ThyroidPrint® on theIdylla™ platform
• GeneproDx will lead the development of the Idylla™ThyroidPrint® test
• Biocartis will be responsible for the distribution of the testthrough growing global commercial infrastructure of Idylla™instruments
3
14
• 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, excluding molecular surveillance
• 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
5,3
10,1
4,8
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 distributor markets (including Japan, excluding China)2 Current Idylla™ offering includes Idylla™ assays in Melanoma (BRAF), Colorectal (KRAS, NRAS, BRAF and MSI), Lung (EGFR), GeneFusion3 Pipeline includes assays in 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. 11m deaths/year globally2, annual healthcare costs est. at > USD 60bn in the US alone3
• High unmet need: current markers are not rapid (blood cultures) or non-specific (PCT, CRP)4; increased risk in pandemic times
• Fast clinical decisions impact patient outcome
• Idylla™ tests:
• SeptiCyte® RAPID5 (with Immunexpress)
• Idylla™ EndPoint Test (with EndPoint Health): aims at enabling biomarker-based therapeutic decisions in patients with critical illnesses6, such as sepsis
• Pandemic: more decentralized MDx testing, faster installed base building in acute settings
• Support Intensive Care Unit (ICU)1
positioning, together with SeptiCyte®
RAPID5 on Idylla™
• Idylla™ tests:
• Idylla™ SARS-CoV-2 Test (CE-IVD,EUA pending)
• Idylla™ SARS-CoV-2/Flu/RSV Panel (CE-IVD)
15 1 The Idylla™ SARS-CoV-2 Test and the SeptiCyte® RAPID (CE-IVD) test on Idylla™ are intended for use in microbiology labs; 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; 4PCT = 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 of infection, such as body temperature and white blood cell (WBC) count, may not be specific; 5 SeptiCyte® RAPID is a host-response test that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis; 6 The Idylla™ Endpoint test is intended to be a PCR based mRNA-expression classifier test that aims at enabling biomarker-based therapeutic 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 MDxsegments
• Idylla™’s unique multiplexingplatform capabilities allow entryinto this market
Towards 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
16 1 A Seattle-based (WA, US) molecular diagnostic company; 2 LifeArc, formerly known as the Medical Research Council Technology (MRC Technology, MRCT) is a London based life science medical research charity; 3 Including research, regulatory oversight, clinical implications, reliability and access; 4 CDx = Companion Diagnostics = A CDx test is a test used as a companion to a therapeutic drug, that helps predict if a patient is likely to respond to a treatment or not; 5 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. The Idylla™ SARS-CoV-2 Test was CE-marked on 10 November 2020 and in August 2020, Biocartis submitted a notification of intent to distribute and request for ‘Emergency Use Authorization’ (EUA) from the US FDA for the Idylla™ SARS-CoV-2 Test; 6 More information here
Partnership Immunexpress
• March 2020: agreement with Immunexpress1
expanded with co-commercialization agreement for SeptiCyte® RAPID test for use on Idylla™
• End December 2020, 510(k) submission with US FDA of the SeptiCyte® RAPID, led by Immunexpress, was completed
Partnership LifeArc
• Announced in September 2020• Agreement with LifeArc2 expanded • Now also includes development of highly
innovative prototype assays in infectious and immune related diseases on Idylla™
Partnership Endpoint Health
• Announced in November 2020• Aimed at the development & commercialization
of a novel CDx4 test on Idylla™ for critical illnesses
Idylla™ SARS-CoV-2 Test
• August 2020: notification of intent submitted to distribute & request for ‘Emergency Use Authorization’ (EUA) from US FDA5
• November 2020: CE-IVD launch announced• Ongoing development of Idylla™ SARS-CoV-2
Panel
SeptiCyte® RAPID
• October 2020: Biocartis announced market release of SeptiCyte® RAPID test on Idylla™(CE-IVD)
• December 2020: US FDA 510(k) submission SeptiCyte® RAPID (led by Immunexpress) completed
1 2 3
4 5Idylla™ SARS-CoV-/Flu/RSV Panel
• 2 Sept 2021: launched as CE-IVD• Detects, in 1 single cartridge, SARS-CoV-2,
Flu A/B and RSV nucleic acids, results in ca. 90 minutes, < 2min. hands-on time
• Clinical performance study6: 98% overall concordance compared with other currently used methods
6
SeptiCyte® PLUS on Idylla™
17
Idylla™ Syndromic Panel(> 20-30 pathogens multiplexed)
Idylla™ SARS-CoV-2 Test and Idylla™ SARS-CoV-2 Panel (CE-IVD)
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
18
Cartridge Development USACE Japan China
EUA Pending*
Regulatoryprocess 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. SeptiCyte® RAPID on Idylla™ in collaboration with Immunexpress. Idylla™ Endpoint test in collaboration with Endpoint HealthThe 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.* 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. The Idylla™ SARS-CoV-2 Test was CE-marked on 10 November 2020 and in August 2020, Biocartis submitted a notification of intent to distribute and request for ‘Emergency Use Authorization’ (EUA) from the US FDA for the Idylla™ SARS-CoV-2 Test
Ongoing
Pandemic menu
Pandemic menu
EUA submission timing
TBC
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
19
20
Commercial cartridge volume
Total operating & product income
• Total operating income of EUR 23.1m, versus EUR 17.6m in H1 2020• Product income +62% to EUR 18.5m, versus EUR 11.4m in H1 2020
• 156k commercial Idylla™ cartridges sold, almost twice as high as in H1 2020 (+96%)• Q1 2021 marked by 70% growth, followed by an even stronger +136% in Q2 2021• Robust growth in oncology across all regions• Solid contribution from infectious diseases
• + 189 new Idylla™ placements in H1 2021 (versus 101 in H1 2020)• Installed base of 1,770 Idylla™ instruments end of H1 2021• Increasing average annualized cartridge consumption per Idylla™ instrument (for period H1 2021): 209
Installed base
Partnerships
1 ASP = Average Sales Price; 2 COGS = Costs of Goods Sold; 3 This assay is aimed at predicting a patient’s risk of nodal metastasis in melanoma. Under the terms of the partnership agreement, SkylineDx will lead the development of the Merlin Assay on Idylla™, while Biocartis will lead the commercialization in Europe through its growing Idylla™ network; 4 Defined asthe world excluding European direct markets, US, China and Japan; 5 RUO = Research Use Only, not for use in diagnostic procedures; 6 A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval(PMA). A 510(k) or Premarket Notification (PMN) with the US FDA is required when introducing a device into commercial distribution for the first time. Source: https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances, last consulted on 17 August 2021; 7 For the detection of MSI (Microsatellite Instability) and to aidin the differentiation between sporadic colorectal cancer and potential Lynch Syndrome; 8 The Panel detects SARS-CoV-2, Flu A/B and RSV (respiratory syncytial virus) nucleic acids in one single cartridge within approx. 90 minutes and was launched as CE-IVD
Idylla™ test menu
Cash position • Cash and cash equivalents of EUR 85.0m end of H1 2021
Cartridge ASP & gross margin
• Cartridge oncology ASP1 stable: EUR 104; ASP of the Idylla™ SARS-CoV-2 Test lower than last year, in line with expectations and resulting in an overall ASP of EUR 95.
• Gross margin on products: 8% (vs 18% in H1 2020):
• Lower ASP of Idylla™ SARS-CoV-2 Test
• Temporarily higher COGS2 due to lower production volumes on ML2 caused by global shortage of reagent supplies
• Ramp-up of staff in anticipation of increasing volumes in H2 2021
• New partnership SkylineDx: development of Merlin Assay3 on Idylla™• Expanded partnership AstraZeneca: improve access to Idylla™ EGFR testing products in EU and global distributor4 markets
• Encouraging first market demand for the Idylla™ GeneFusion Assay (RUO5), launched end Q1 2021• First oncology assay US FDA submission: 510(k)6 notification for the Idylla™ MSI Test7
• Post the reporting period: successful CE-IVD launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel8
80k
156k
H1 2020 Year-over-year growth H1 2021
21
Installed base (in # instruments) Commercial cartridge volume (x 1,000)
+ 96%
~
• Increasing annualized average cartridge consumption per Idylla™ instrument: 209
• In part reflecting high utilization for infectious disease testing
• Q1 2021 marked by 70% growth• Followed by an even stronger +136% in Q2 2021• Robust growth in oncology across all regions• Solid contribution from infectious diseases, comparable to
H2 2020 volumes against backdrop of declining global COVID-19 testing volumes
1,581
1,581
+189 1,770
End 2020 Increase H1 2021 End H1 2021
22
• Commercial cartridge volumes +150%
• Slowdown Idylla™placements: constrained hospital budgets following the pandemic
• Growth driven by increased demand for oncology biomarker testing, return to pre-pandemic oncology biomarker testing volumes more disparate across the US
• Infectious diseases: demand for SARS-CoV-2 testing in H1 2021 significantly down from 2020 levels
• Strong increase new Idylla™placements
• Drives continued growth of EU cartridge volumes
• Strongest growth in oncology
• Combined with acquisition of new European customers in need for rapid SARS-CoV-2 testing for safe access to hospitals, events, travel
Europe
• Registration Idylla™instrument in China expected by end 2021
• Idylla™ assay registrations expected to follow earliest end 2022 in both countries
• Good progress in local manufacturing set-up in China during H1 2021, with local manufacturing of first cartridge volumes needed for local registration of the assays expected in H1 2022
1 Distributor markets = World excluding European direct markets, US, China and Japan;2 In China, Biocartis established a joint venture (‘China JV’) with Guangzhou Wondfo Biotech Co., Ltd (SHE: 300482), a fast-growing diagnostics leader in China. In Japan, Biocartis is collaborating with Nichirei Biosciences
• Strong performance in terms of Idylla™placements
• Cartridge volume regained traction in oncology in all regions
• Registration completed in Russia for the Idylla™platform, Idylla™ BRAF Mutation Test (CE-IVD) and Idylla™ EGFR Mutation Test (CE-IVD)
• Registration completed in Taiwan for the Idylla™ MSI Test (CE-IVD)
Distributor markets1 China & Japan2US
23
• Gene fusions have become important biomarkers for cancer diagnosis, prognosis and selection of targeted therapies1
• The discovery & research for further understanding of fusion genes across multiple cancer types may provide more effective therapies in the future
• Current gene fusion testing techniques are complex: • Require combination of different
technologies2, often only available in different laboratories, to test all biomarkers
• Implies need for sufficient sample quality & quantity: difficult to obtain, esp. for certain cancers including lung cancer
* RUO = Research Use Only, not for use in diagnostic procedures; 1 Stransky et al. The landscape of kinase fusions in cancer. Nat Commun. 5, 4846, 2014; Mertens et al. The emerging complexity of gene fusions in cancer. Nat Rev Cancer 15, 371-381, 2015; 2 Techniques used to detect NTRK gene fusions include DNA-based next-generation sequencing (NGS), RNA-based NGS, reverse-transcriptase PCR (RT-PCR), fluorescence in situ hybridisation (FISH), and immunohistochemistry (IHC). Source: OncologyPro, ESMO, see here, last consulted on 15 March 2021; 3 FFPE = formalin fixed, paraffin embedded; 4 The concordance study was performed on NSCLC (non-small cell lung cancer) and thyroid cancer samples with prototype cartridges but re-analyzed with final Idylla™ GeneFusion Assay (RUO) decision tree. Moreover, the Idylla™ GeneFusion Assay was able to generate accurate results in 29/32 inconclusive IHC and FISH results. Preliminary data can be found on https://www.biocartis.com/en/meetidylla/idylla-oncology-assays General note: An IVD version of the Idylla™ GeneFusion Panel is 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.
Detection of ALK, ROS1, RET & MET Exon 14 skipping plus NTRK1/2/3 fusion screening in one cartridge
Fully automated molecular testing platformOn-demand testing
<2 minutes hands-on time (HOT)Assay turnaround time (TAT) of approx. 180 min.
Directly from 1-3 FFPE3 slices
Preliminary data4 comparing the Idylla™ GeneFusion Assay (RUO) with today’s frequently used technologies such as Immunohistochemistry, FISH or NGS2, show excellent results of the Assay, with concordance up to 100%
The Idylla™ GeneFusion Assay (RUO) highly multiplexed panel of biomarkers, the first FFPE3 RNA4-based assay on Idylla™
24
• Announced 20 April 2021: US FDA 510(k) submission1 of Idylla™ MSI Test2 for use as an IVD diagnostic device intended for the identification of microsatellite instability (MSI) status in colorectal cancer (CRC) to aid in the differentiation between sporadic CRC and potential Lynch syndrome
• Today, MSI testing is recommended in the guidelines for CRC patients for screening for Lynch syndrome3
• MSI testing today still underused due to complexity of current methods
• Idylla™ MSI Test allows fully automated MSI testing, providing info on the MSI status4 of CRC tumors within approx. 150 minutes, without the need of a reference sample
• Once 510(k) clearance is obtained, both large & small US labs are expected to benefit from this fast & easy-to-use Idylla™ MSI testing thanks to fully automated sample-to-result nature of Idylla™ platform
1 A 510(k) or Premarket Notification (PMN) with the US FDA is required when introducing a device into commercial distribution for the first time. Source: US FDA; 2 The Idylla™ MSI Test, for use on theIdylla™ system, is intended for the qualitative identification of microsatellite instability (MSI) in colorectal cancer (CRC) tumors and to aid in the differentiation between sporadic CRC and potential LynchSyndrome. The clinical performance of this device to guide treatment of MSI-H patients has not been established; 3 Van Cutsem et al. (2016) ESMO Consensus Guidelines for the management ofpatients with mCRC. Annals of Oncology 27, 1386; NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Colon Cancer V.2.2018. Accessed 25 July 2018. See www.NCCN.org; 4 TheIdylla™ MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid
• SkylineDx: Dutch & US based private biotech company activein oncology & inflammatory diseases MDx
• Immediate market development ahead of IVD strategy:
• LDT4 version of Merlin Assay through CAP/CLIA certifiedlaboratory in San Diego (CA, US)
• Molecular subtyping test kit for IVD use underdevelopment for Europe
• Commercialization by Biocartis in Europe through itsgrowing Idylla™ network
• Access to SkylineDx’s highly valuable biomarker content:
• Additional novel tests in varying stages of development
• Biocartis to invest up to EUR 10m in secured convertiblenotes issued in different project-based instalmentsthroughout the collaboration
• Expected attractive value-based pricing
25
About melanoma & Merlin Assay on Idylla™ About SkylineDx & the agreement
• Melanoma is deadliest form of skin cancer: prognosis & treatment decisions depend on disease staging
• Current staging methods include an invasive SLN biopsy1:
• Carrying a >10% risk of complications2 whereas
• 80-85% are unnecessary as no nodal metastases are found2
• Principal agreement announced 22 April 2021:
• Development by SkylineDx of its novel Merlin Assay, on Idylla™
• Predicting a patient’s risk of nodal metastasis in melanoma, identifying patients who may safely forgo an SLN biopsy1
• Biocartis will lead commercialization in Europe through its growing Idylla™ network
• Complements Biocartis’ current BRAF assay offering3
1 A sentinel lymph node biopsy (SLNB) is a surgical procedure used to determine whether cancer has spread beyond a primary tumor into the lymphatic system. Source: Mayo Clinic, https://www.mayoclinic.org/tests-procedures/sentinel-node-biopsy/about/pac-20385264, last consulted on 21 April 2021; 2 Ascha M, et al. Ann Plast Surg 79:509-515, 2017, https://journals.lww.com/annalsplasticsurgery/Abstract/2017/11000/Identification_of_Risk_Factors_in_Lymphatic.22.aspx; Bellomo et al. JCO Precision Oncology, https://ascopubs.org/doi/10.1200/PO.19.00206; 3 The Idylla™ BRAF Mutation Test (CE-IVD) is validated for use in metastatic melanoma; 4 A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. Source: US FDA, last consulted on 19 August 2021
• Panel showed excellent performance in the clinical
performance study with 98% overall agreement
compared with other currently used methods
• Timing of Emergency Use Authorization (‘EUA’)
submission with the US FDA to be decided
26
About the Panel Clinical performance
• Fully automated rRT-PCR1 test intended forqualitative detection of SARS-CoV-2, Flu A/B andRSV nucleic acids in nasopharyngeal swabspecimens from individuals suspected ofrespiratory infections by their healthcare provider
• Collected in viral transport medium2, can bepipetted directly into the cartridge
• Panel includes fully automated nucleic acidtesting with the extraction, amplification anddetection in a single-use cartridge
• Less than 2 minutes hands-on time, results inapprox. 90 minutes
1 Real-Time Reverse Transcription-Polymerase Chain Reaction; 2 Of which 400 µl VTM is used in Idylla™; 2 Performance was evaluated across two arms of a clinical evaluation, all samples were residual nasopharyngeal swab in viral transport media. In the first arm 322 specimens were collected to evaluate the performance of the Idylla™ COVID-19/Flu/RSV Panel compared to the DiaSorin Molecular Simplexa™ Flu A/B & RSV Direct. In the second arm 341 specimens were collected to evaluate the performance of the Idylla™ COVID-19/Flu/RSV Panel compared to the Luminex Aries® SARS-COV-2 Assay. More information here
27
• Successful transfer Idylla™ EGFR Mutation Test (CE-IVD) to second manufacturing line ‘ML2’ during H1 2021
• Key oncology assays now all on ML2 line
• Product gross margin improvement temporarily held up, global pandemic shortage of certain reagents limited planned production volumes
ML2 cartridge manufacturing line facts• 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)
• Key to support volume growth & cost effectiveness
H1 2021: Key oncology assays on ML2 line
28
Fire incident on 30 July 2021
• Immediate actions taken to mitigate loss of finished products & raw materials, and temporary unavailability of high-throughput ML2 line
• Actions to safeguard continued supply to customers:
• Redirection of additional personnel & resources to the unaffected ML1 line to temporarily increase production
• Orders placed to replenish critical reagents lost in fire to minimize production delay
• Prioritization of oncology & partner project tests, which also reduces the number of available Idylla™SARS-CoV-2 Test cartridges
Despite impact of the fire...
• Biocartis to confirm a 40% cartridge volume growth for 2021:
• Subject to timely and sufficient availability of reagents
• Subject to full restart of the ML2 line, now expected by 2nd half of September
• Delays in supply of assay-specific reagents may cause certain Idylla™ products to be temporarily unavailable to meet the entire customer demand
29
• Evaluation of new concept ongoing for simplified, cost-efficient Idylla™ cartridge
• In the mid-to long term, expected to acceleratereduction of cartridge manufacturing cost alongside ongoing development of new Idylla™technology1 for offline customization of Idylla™cartridge
• Reduced complexity of the cartridge for infectious diseases and likely also for certain oncology assays
• Fully compatible with existing Idylla™ platform
1 With the support of VLAIO, Flanders Agency for Innovation and Entrepreneurship. The technology is aimed to tap into new market opportunities with customized and personalized products
What and why Status & timelines
• Feasibility already externally confirmed by reputable global contract manufacturing organization
• Investment decision still subject to completion of concept design
• Ongoing and future assay menu investments in infectious diseases and oncology under review
Idylla™ standard: 40+ parts
New Idylla™: ~12 parts
30
Despite impact of the fire, Biocartis confirms its 2021 guidance at 40% growth target for commercial cartridge volumes:
• Commercial cartridge volume: Targeting a year-over-year growth of 40%, or commercial cartridge volumes of 320k.
• Subject to timely availability of reagent raw materials for Idylla™ cartridges
• Subject to restart of the ML2 line by 2nd half of September
• Installed base: Targeting 300-350 new Idylla™ instrument placements
• Cash position: Targeting at least EUR 50m cash position at year-end, provided timely collection of insurance claims related to the fire incident
31
Oncology test menu Infectious disease (partner) test menu
510(k) clearance with US FDA of
SeptiCyte® RAPID on Idylla™
(Immunexpress) is pending
Timing of Emergency Use Authorization
(‘EUA’) submission of Idylla™ SARS-
CoV-2/Flu/RSV Panel with the US FDA
to be decided
New simplified, cost-efficient CART concept
Concept design still to be completed
Will impact decision to invest in
manufacturing equipment and the actual
development of new and existing Idylla™
assays based on this concept
Outcomes of the assessment and
associated development timelines will be
communicated at a later stage
Launch Idylla™ EGFR-BRAF+ Mutation
Assay:
• Suspended awaiting completion of
the new simplified, cost-efficient
cartridge concept
• Timelines will be communicated at
a later stage
Launch Idylla™ ABC (Advanced Breast
Cancer) Assay in collaboration with
LifeArc expected in H2 2022
Idylla™ MSI Test US FDA 510(k)
pending
Shareholder overview (as per 13 Sept 2021) Coverage
Note: The percentages above are based on the most recent transparency notifications received by Biocartis. See the Biocartis investor website for more details.
Listing: Euronext BrusselsISIN: BE0974281132 Ticker: BCART
Stock facts
Dylan van Haaften
Kris Kippers
Thomas Vranken
Alexandru Cogut
Daan Vandenberk
32
Shareholder >3% table # shares % shares
Invesco, Ltd. (1) 6,969,077 12.10%
Johnson & Johnson Innovation – JJDC, Inc (2) 5,481,128 9.5%
ParticipatieMaatschappij Vlaanderen NV (Flemish Region) (3) 2,342,345 4.07%
Credit Suisse Group AG (4) 1,818,193 3.16%
Other institutional and retail investors 40,934,920 71.17%
Total outstanding shares (non-diluted) 57,545,663 100,00%
• 10 November 2021 Q3 2021 Business Update
• 24 February 2022 2021 full year results
• 31 March 2022 Publication 2021 annual report
33
Biocartis Investor RelationsGeneraal de Wittelaan 11B
2800 Mechelen
BELGIUM
tel. +32 15 63 17 29
www.biocartis.com
34
36
Additional details (in EUR 1,000)
Product sales revenue H1 2021 H1 2020
Idylla™ system sales 3,715 1,837
Idylla™ cartridge sales 14,749 9,584
Product sales revenue 18,463 11,421
Collaboration revenue H1 2021 H1 2020
R&D services 2,590 4,623
License fees 50 123
Milestones 0 0
Collaboration revenue 2,640 4,746
Breakdown total operating income
In EUR 1,000 H1 2021 H1 2020
Product sales revenue 18,463 11,421
Collaboration revenue 2,640 4,746
Service revenue 748 530
Total revenue 21,851 16,697
Grants and other income 1,206 909
Total operating income 23,057 17,606
37
Condensed income statement
In EUR 1,000 H1 2021 H1 2020
Total operating income 23,057 17,606
Cost of goods sold (17,059) (9,233)
R&D expenses (23,389) (20,303)
S&M expenses (7,740) (7,931)
G&A expenses (7,935) (6,491)
Total operating expenses (56,132) (43,958)
Operating result (33,075) (26,352)
Net financial result (4,249) (5,129)
Share in results of associates (101) -195
Income taxes 149 118
Net result (37,276) (31,558)
Comments
• Total operating income of EUR 23.1m, versus EUR 17.6m in H1 2020:o Product revenues +62% to EUR 18.5m in H1 2021
o Cartridge sales revenues +54%o Instrument sales revenues doubled on the back of 189 new
instrument placements, +88 year-over-yearo Collaboration revenues EUR 2.6m (R&D services to partners):
highly sensitive to timing of collaboration projects
• Higher COGS mostly driven by volume growth
• Gross margin on products 8% versus 18% in H1 2020:• Lower ASP of the Idylla™ SARS-CoV-2 Test • Lower than expected production volumes on ML2
• Operating expenses (excl. cost of sales) EUR 39.1m in H1 2021 (H1 2020: EUR 34.7m): planned acceleration & diversification of the Idylla™ test menu, both in oncology & in infectious diseases
• Net result EUR 37.3m compared to EUR 31.6m in H1 2020
38
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 restricted cash related to KBC Lease financing
• The net cash outflow from operating and investing activities amounted to EUR 35.8m in H1 2021 compared to EUR 25.6m in H1 2020
• Increased outflow is attributable to:
• Increased operating loss
• Large one-off collection of EUR 5.2m tax credit in 2020
• Cash and cash equivalents at 30 June 2021 amounted to EUR 85.0m
In EUR 1,000 H1 2021 H1 2020
Result for the period (37,276) (31,558)
Depreciation and amortization 4,799 5,010
Impairment losses 598 721
Net financial result & other adjustments
4,636 5,411
Working capital changes (3,282) (525)
Taxes & interests paid (3,227) (3,585)
CF operating activities (33,752) (24,526)
CF investing activities (2,087) (1,028)
CF financing activities (3,518) (3,456)
Total net cash flow1 (39,357) (29,010)
Cash and cash equivalents2 84,905 149,674
Financial debt 149,412 165,259
• 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); 6 NCCN Guidelines version 8.2020 Non-small Cell Lung Cancer; 7 An IVD-version of the Idylla™ GeneFusion Panel is 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.
Idylla™ ctEGFR Mutation Assay (RUO)
About lung cancer and existing lung cancer testing
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
39
• 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
• 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
Idylla™ GeneFusion Panel7
(RUO)
• Chromosomal translocations can produce gene fusions leading to uncontrolled tyrosine kinase activity
• Tyrosine kinase inhibitors are recommended by international guidelines6 for NSCLC patients with a specific gene fusion
• Idylla™ GeneFusion Assay launched on 22 March 2021
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™ EGFR/BRAF+ Mutation Assay will first be launched as RUO. An IVD version of the Idylla™ GeneFusion Panel is 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 NSCLC = Non small cell lung cancer; 2 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
IN DEVELOPMENT: Idylla™ EGFR/BRAF+ Mutation Test*
• Detection of >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
NSCLC2
• 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 NSCLC1
+
40
Initial performance expectations as from early testing of prototypes. The Idylla™ call is a result of a preliminary decision tree algorithm.An IVD version of the Idylla™ GeneFusion Panel is 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
41
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
42 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. An IVD version of the Idylla™ GeneFusion Panel is 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
+
-
43
• 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
44
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
45
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
46
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
47
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