Biocartis Corporate presentation · 2020. 6. 17. · This presentation has been prepared by the...
Transcript of Biocartis Corporate presentation · 2020. 6. 17. · This presentation has been prepared by the...
BiocartisCorporate presentation
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.
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31 Exact Sciences Corp. (NASDAQ: EXAS) acquired Genomic Health on 8 November 2019; 2 Guangzhou Wondfo Biotech Co., Ltd. (‘Wondfo’, SHE: 300482) is a fast growing diagnostics leader in China; 3 RoW = Rest of the World. RoW is defined here as the world excluding European direct markets, US, China and Japan
Differentiated technology
Focus on oncology
Attractive market
Worldwide commercial footprint
Commercially proven
Positioned for further value creation
• Idylla™: first fully automated sample-to-result qPCR platform• Superior and 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 through amongst others further penetration of the US market & initiation of commercialization in China and 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 and immunotherapy and to move into monitoring• Content partners such as Exact Sciences1 to add high value genomic signatures to the menu)• Validation via partnerships with pharma (e.g. Amgen, Merck KGaA, AstraZeneca, Bristol-Myers Squibb, Kite/Gilead
• Direct sales approach in US, Canada and Western Europe
• Strategic partnerships established for China & Japan: Joint venture with Wondfo2 for Chinese market and commercial collaboration with Nichirei Bio for Japanese market
• RoW3 distribution model: partnerships with local distribution partners for relevant rest of the word MDx markets supported by Biocartis RoW sales team
• Installed base of 1,310 Idylla™ instruments end of 2019, +337 net addition in 2019• Commercial volume of 175k cartridges in 2019, representing a +32% year-over-year growth• Total operating income of EUR 38m in 2019 with product sales revenues of EUR 24m
• Global MDx market of USD 6.5bn; oncology fastest growing segment with high double digit annual growth rates• Large, global initial customer base (i.e. pathology labs) with opportunity to expand (e.g. labs that want to step into MDx testing) • Potential to add new customer segments
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.
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 turnaround time of
90 to 150* minutes
* Based on turnaround times of current on-market oncology tests5
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
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• 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
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Only selected studies shown on slide
Q1 2020 publications - Europe
• Seven1 new Idylla™ performance publications2 were issued in Europe
• All Idylla™ studies demonstrated excellent performance of Idylla™ compared to other methods, in combination with the ease of use and fast turnaround time of the Idylla™ platform
• Studies included, amongst others, a feasibility study3 on the Idylla™ NRAS-BRAF Mutation Test4 to research the direct use of thyroid FNA (Fine Needle Aspirate) samples as a Rapid On site Molecular Evaluation (ROME) solution for the rapid and easy detection of NRAS and BRAF mutations without having to send out the samples to specialized, centralized labs
Q1 2020 publications - US
5 R. Gadde et al., ‘Validation of the Idylla™ EGFR Assay for Rapid Assessment of EGFR Mutation Status in Non-small Cell Lung Cancer’, Dartmouth Hitchcock Medical Center, Lebanon, NH; H Yaziji et al., ‘Validation of a Rapid PCR Assay for Microsatellite Instability Testing in Colorectal Cancer’, Vitro Molecular Laboratories, Miami, FL; J Gralewski et al., ‘Detection of EGFR Exons 18-21 Hotspot Mutations Using a Fully-Automated, Cartridge-Based Platform with Ultra-Rapid Turnaround Time: A Comparison Study with Conventional Next GenerationSequencing’, University of New Mexico, Albuquerque, NM; P. Matthews et al., ‘Clinical Impact of Rapid Biomarker Testing in Non-Small Cell Lung Cancer in a Community Setting’, William Osler Health System, Brampton, ON, Canada
• During the global annual pathology conference USCAP, that took place in Los Angeles, CA (US) between 2 - 4 March 2020, four Idylla™ abstracts and posters5 published by key oncology opinion leaders, including amongst others Dartmouth-Hitchcock Medical Center (Lebanon, New Hampshire, US), Vitro Molecular Laboratories (Miami, Florida, US), the University of New Mexico (Albuquerque, New Mexico, US) and the William Osler Health System (Brampton, Ontario, Canada)
• Strong data shown of Idylla™ assays (RUO) including several studies that used the Idylla™ EGFR Mutation Assay (RUO), which demonstrated reliable and rapid EGFR testing to be used to complement conventional NGS testing
1 Of which two studies were published in epub, ahead of print in Q2 20202 De Luca C et al., ‘Rapid On-site Molecular Evaluation in thyroid cytopathology: A same-day cytological and molecular diagnosis’. Diagn Cytopathol. DiagnCytopathol. 2020 Apr;48(4):300-30. Epub 6 Jan 2020; Zwaenepoel K et al., ‘Clinical Performance of the Idylla™ MSI Test for a Rapid Assessment of the DNA Microsatellite Status in Human Colorectal Cancer’. J Mol Diagn. March 2020; 22 (3): 386-395.. Epub 24 Dec 2019; Chevalier L et al., ‘EGFR molecular characterization in non-small cell bronchic cancer: comparative prospective study by NGS and Idylla™ platform technologies’. Annales de Pathologie. Feb 2020; Merlin MS et al., ‘Rapid fully-automated assay for routine molecular diagnosis of BRAF mutations for personalized therapy of low grade gliomas’. Pediatr Hematol Oncol. 2020 Feb;37(1):29-40. Epub 23 Oct 2019; Franczak C et al., ‘Evaluation of KRAS, NRAS and BRAF mutations detection in plasma using an automated system for patients with metastatic colorectal cancer’. PLoS One. 15 Jan 2020 ;15(1); Bocciarelli C. et al., ‘Evaluation of the Idylla™ system to detect the EGFRT790M mutation using extracted DNA’. Pathol Res Pract. 2020 Jan;216(1). Epub 2 Dec 2019; Boureille A et al. ‘Rapid detection of EGFR mutations in decalcified lung cancer bone metastasis’, Bone Oncol. January 2020 (Epub ahead of print)3 De Luca C et al., ‘Rapid On-site Molecular Evaluation in thyroid cytopathology: A same-day cytological and molecular diagnosis’. Diagn Cytopathol. DiagnCytopathol. 2020 Apr;48(4):300-30. Epub 6 Jan 20204 The Idylla™ NRAS-BRAF Mutation Test is intended for use on FFPE samples (Formalin Fixed, Paraffin Embedded) and not for use on FNA samples. Please refer to the Biocartis product labeling for intended use of the assay
• Reduction of time-to-result from weeks to hours
• Sample-to-result (i.e. full automation) capabilities for:
o Solid biopsies: FFPE6*, FNA7^, fresh samples^
o Liquid biopsies: Plasma*, whole blood^, urine^
Idylla™ unique selling points
• Ability to combine advantages of point-of-care testing with performance of lab reference testing: enabling MDx in virtually any lab setting
1
2
3
Fast growing market
• Represents 19% of the USD 6.5bn total MDx marketin 20161
• Fastest growing segment in MDx, expected to grow 26% per annum (doubling of market) to 20202
• Global incidence ~18.1bn; growing at ~2.5% per
annum3
• Increased need for MDx testing:
o Broader availability of targeted therapies
o Significant clinical pipeline targeted therapies: in
2015, >800 cancer treatments were in
development in the US4, ~70% has potential to be
personalized medicines5
o Addition of new application areas: immuno-
oncology, liquid biopsy testing, etc.
• Growth of decentralized market (i.e. under-penetrated
customer potential)1. MarketsandMarkets, 2017. 2. Berenberg research. 3. Globocan 2018, Estimated cancer incidence, mortality and prevalence worldwide, WHO International Agency for Research on Cancer. 4. PhRMA, “Medicines in Development for Cancer,” September 2015, http://phrma.org/sites/default/files/pdf/oncology-report-2015.pdf; American Association for Cancer Research. 5. PhRMA, Oncology Report 2015. 6: FFPE = Formalin Fixed Paraffin Embedded. 7: FNA = Fine Needle Aspirates. * Validated sample type. ^ Research Use Only.
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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.
Targeted therapies Pan-tumor therapies Gene signatures Immuno-oncology Liquid biopsy
• Assess tumor information via liquid samples
• Clinical valueincreasingly demonstrated
• Front-runner applications:o Therapy selectiono On-therapy
monitoringo Post-treatment
Minimal Residual Disease (‘MRD’)
• Therapy selection driven by 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
• ‘Fifth pillar’ of cancer treatment
• Consists of several therapeutic classes, e.g.:o Immune checkpoint
inhibitorso Cell and viral
therapieso Vaccines
• High unmet need for underlying clinical testing
• MDx tests that target applications beyond therapy selection, e.g.:o Cancer risko Prognosis
• Often high value once validated and clinical value demonstratedo Critical information for
medical decision-making
• Therapy selection driven by specific cancer mutations
• Significant pipeline of new targeted therapies across cancer types
• Exampleso Zelboraf®1 (BRAF)o Tagrisso®2 (EGFR)o Erbitux®3 (RAS)o Vectibix®4 (RAS)
Selection
Cancer Treatment
Surg
ery
Radia
tion
Targ
ete
d T
hera
py
Imm
unoth
era
py
Chem
oth
era
py
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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 changeSee appendix for more details
+ 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 CRC, 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
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KRAS
NRAS-BRAF
ctKRAS
ctNRAS-BRAF
MSI
KRAS-NRAS-BRAF
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Cartridge Development1 RUO2 USA Partnerships
• Amgen
• Amgen
• Merck KGaA
• Merck KGaA
• Bristol-Myers Squibb
1. Generally includes analytical validation; 2. Research Use Only, not for use in diagnostic procedures; 3. CE-marked IVD; 4. All publications, abstracts & posters are available on www.biocartis.com/publications; 5. ABC = Advanced Breast Cancer; 6. IO = Immuno-oncology; 7. FNA = Fine Needles Aspirates; 8. PMA = Pre-Market Approval; 9. 510(k) clearance = a premarket submission made to the US FDA. 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.
Lung
EGFR
ctEGFR4
BRAF4
KRAS4
GeneFusion
EGFR/BRAF+
Mela
-nom
a
BRAF
ctBRAF
NRAS-BRAF4
KRAS (pancreatic cyst fluid samples)4
NRAS & BRAF (thyroid FNA7 samples)4
MSI (pan-tumor)4
SeptiCyte® RAPID Test on Idylla™ Idylla™ SARS-CoV-2 test
Bre
ast Oncotype DX Breast®
Idylla™ ABC5 Assay
• Exact Sciences
• LifeArc
• Exact Sciences
Colo
rect
al
PMA8
IO6 MSI
Cell therapy monitoring
• Bristol-Myers Squibb
• Kite/Gilead
• AstraZeneca
• AstraZeneca
CE3 Japan
= liquid biopsy
= solid biopsy
PMA8
Completed
Ongoing
To be initiated
China
510(k)9
PMA8
Oth
er
= launched
Ur. Oncotype DX Prostate®
• Immunexpress• Multiple undisclosed partners
EUA
Potential pathology customer base
• Initial Idylla™ customer base
• Around 16,000 pathology laboratories worldwide1
• Significant number of hospitals not performing MDx today,
table below shows situation in US2:
Sales approach pathology labs
• Initial focus on labs offering MDx testing (=
existing market)
• Second phase focused on targeting labs that
want to step into MDx testing (= new market)
Additional customer bases
• Ongoing menu expansion and content
partnerships could expand Idylla™ customer base
into oncologists, urologists, dermatologists, etc.
1. Biocartis management estimate. 2. Boston Strategic Market Research www.hospitalregisters.com 2014; American College of Surgeons 2000-2011; EMMES 2012, 2015 database.
Unlocking Idylla™ customer base potential
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Hospital segment Number Performing MDx (total)
%
Small 3,816 382 10%
Medium 988 632 64%
Large 420 353 84%
Pharma & biotech companies Content partners Development partners
Focu
s • (Joint) development of CDx1 on Idylla™ platform
• Porting of proprietary biomarker panels developed and validated by third parties on Idylla™ platform
• Development Biocartis Idylla™ assays in partnership with research institutions
Benefit
Bio
cart
is • Faster commercial adoption, higher marketshares
• Proprietary 3rd party content on Idylla™ platform
• Lowered menu development costs
Part
ners
UK based medical research charity2
Singapore’s Agency for Science, Technology and
Research4
1. CDx = Companion Diagnostics2. 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 cancers3. Partnership is with ETPL, the commercialization arm of A*STAR
Benefit
part
ners
• Better and faster selection of eligible patients for targeted therapies given faster TaT & high sensitivity:o Fast TaT: reduces competition with
therapies not requiring a biomarkero High sensitivity: more patients detected
with relevant biomarkers
• Accelerated global roll-out of content
• No platform education needed: focus on content education
• Realization of cost efficiencies
• Contribution to medical innovation• Knowledge sharing and building
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* The title of the slide ‘targeted therapies’ 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 CDx = companion diagnostics; 2 RUO = Research Use Only, not for use in diagnostic procedures; 3 On 15 June 2017, MRC Technology changed its name in LifeArc. LifeArc has been involved in helping to deliver a number of therapies including Keytruda (pembrolizumab, marketed by MSD) which is an important immunotherapy treatment for various cancers; 4 FFPE = Formalin Fixed, Paraffin Embedded
LifeArcAstraZeneca
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• Partnership broadened on 22 January 2020
• Enables collaborative development & commercialization of Idylla™ tests in support of AstraZeneca’s pharmaceutical products, such as CDx1 development projects
• Specifics new agreement:o Ongoing European prospective study Idylla™ EGFR
Mutation Test extended to additional countries within & outside Europe
o New: study to evaluate if liquid biopsy testing using the Idylla™ ctEGFR Mutation Assay (RUO2) could provide further benefits to tissue-based EGFR testing
• LifeArc is a co-development partner, focused on developing an Idylla™ breast cancer test
• Due to emerging pipeline of targeted drugs in advanced breast cancer (‘ABC’), Biocartis & LifeArc decided to strengthen positioning of the assay under development
• Idylla™ ABC Panel now targets a multi-gene panel of predictive and resistance-inducing mutations based on an FFPE4 sample
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:
Cancer Treatment
Surg
er
yRadia
tion
Targ
et
ed
Thera
py
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Chem
oth
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py
* 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
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• Therapy selection increasingly driven by genetic make-up of the tumor rather than tissue of origin
• Idylla™ assays increasingly assessed for pan-tumor testing, potentially expanding applicability of current Idylla™ assay menu. Examples of research into new applications include:
KRAS mutations detected in FFPE lung samples1
KRAS mutations detected in pancreatic cyst fluid samples2
NRAS and BRAF mutations detected in FFPE melanoma samples1
NRAS and BRAF mutations detected in thyroid Fine Needle-Aspirates (FNA) samples3
* The title of the slide ‘pan-tumor’ 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 Huang et al. J Mol Diagn. 2019 Sept; 2 The use of the Idylla™ ctKRAS Mutation Assay directly on pancreatic cyst fluid was researched as a solution for direct, rapid KRAS mutation testing, which is especially helpful in cases where cellular content and fluid volume of pancreatic cysts are suboptimal for otherroutine testing (Al-Turkmani M et al. Pancreatic cyst fluid harboring a KRAS mutation. Cold Spring Harb Mol Case Study 5.(2) Apr 2019. Available online on https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6549572/ ; 3 The Idylla™ BRAF Assay and the Idylla™ NRAS-BRAF Assay (RUO) were used to research thedirect use of thyroid FNA samples as a Rapid On site Molecular Evaluation (ROME) solution for the rapid and easy detection of NRAS and BRAF mutations without having to send out the samples to specialized, centralized labs (De Luca C et al. Rapid On-site Molecular Evaluation in thyroid cytopathology: Asame-day cytological and molecular diagnosis. Diagn Cytopathol. 6 January 2020, doi: 10.1002/dc.24378. Epub ahead of print. Available online on https://www.ncbi.nlm.nih.gov/m/pubmed/31904908/) ; 4 Many of these demonstrate importance of pan-tumor MSI testing in non-colorectal cancer types such asendometrial, gastric, ovarian, pancreatic and other cancers in the context of Lynch Syndrome and immunotherapy use. Note: The Idylla™ MSI Test is intended for the qualitative detection of a novel panel of seven monomorphic homopolymer biomarkers for identification of colorectal cancers (CRC) withmicrosatellite instability (MSI)Logos are a selection of the research institutions mentioned that performed an Idylla™ study.
• Various efforts ongoing to demonstrate feasibility of the Idylla™ MSI Test in other cancer types than colorectal cancer: over 30 Idylla™ MSI studies initiated worldwide in 20194
Background collaboration Oncotype DX Breast Recurrence Score® test
• Focused on exclusive test development of proprietary Exact Sciences1
tests on the Idylla™ platform
• Aimed at accelerating adoption and market access around the world of Exact Sciences’ tests
• First test to be developed on Idylla™ is the Oncotype DX Breast Recurrence Score® test, second test is the Oncotype DX Genomic Prostate Score® test
* The title of the slide ‘gene signatures’ 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.Source: Company website; 1 Exact Sciences Corp. (NASDAQ: EXAS) acquired Genomic Health on 8 November 2019; 2 As per March 2020
Background Exact Sciences1
• Exact Sciences Corp. is a leading provider of cancer screening and diagnostic tests, has over 4,000 employees
• Listed on NASDAQ (NASDAQ: EXAS) with a market capitalization of around USD 12bn2
• On-market tests for amongst others colorectal, breast, prostate and colon cancer
• Examines the activity of 21 genes in a patient’s breast tumor tissue to provide personalized information for tailoring treatment based on the biology of their individual disease.
• Only test proven to predict chemotherapy benefit
• Included in all major cancer guidelines worldwide and is now considered standard of care for early-stage breast cancer.
• Examines the activity of 17 genes in a patient’s prostate biopsy sample to provide information on the aggressiveness of their individual disease
• Predicts risk of metastasis and helps to make better informed & more personalized treatment decisions
• Has been validated in > 4,500 patients, which is described in 18 publications
Oncotype DX Genomic Prostate Score® test
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1 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 infection2 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 inflammation3 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)30566-34 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 with support from multiple undisclosed partners announced on 23 April 2020
• Based on the Idylla™ Respiratory (IFV-RSV) Panel5, being designed to detect SARS-CoV-2 from respiratory samples such as nasopharyngeal swabs
• Upon regulatory approval, targeted to help healthcare providers manage COVID-19 pandemic through rapid & easy testing of individuals with flu-like symptoms
• Combined testing solution with SeptiCyte® RAPID Test6 on Idylla™ to facilitate management of patients within hospital intensive care units (ICUs): unique potential to identify patients with severe disease, as recent data7 indicate that sepsis is the most frequently observed complication in COVID-198
• Subject to a successful ‘Emergency Use Authorization’ by the US FDA, launch of Idylla™ SARS-CoV-2 test expected in H2 20209
Idylla™ SARS-CoV-2 test
• Expansion of agreement with Immunexpress Pty Ltd ('Immunexpress') announced on 26 March 2020: co-commercialization of the newly CE-marked IVD SeptiCyte® RAPID Test on Idylla™
• Biocartis will lead commercialization in Europe as exclusive distributor of the SeptiCyte® RAPID Test, Immunexpress will lead commercialization in the US
• The SeptiCyte® RAPID Test is a rapid, host-response1 test that distinguishes sepsis from non-infectious SIRS (systemic inflammatory response syndrome)
• Expected to provide actionable results in about one hour2
• Recent data3 indicate that sepsis is the most frequently observed complication in COVID-194
SeptiCyte® RAPID on Idylla™ (CE-IVD)
19
5 Legally acquired in 2018 from Janssen Diagnostics, a division of Janssen Pharmaceutica NV (‘Janssen’) who co-developed the assay. The Idylla™ Respiratory (IFV-RSV) Panel received received 510(k) clearance by the US FDA on 5 September 20176 Developed in collaboration with Immunexpress. More info here7 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)30566-38 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])9 Subject to interactions with the US FDA. US FDA 510(k) clearance of SeptiCyte® RAPID Test on Idylla™ expected along the same timelines
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. Exact Sciences, Immunexpress)
1
2
3
1 Situation as per 31 December 201920
4
Chinese go-to-market strategy
• Joint venture established with Wondfo for Chinese market
• Chinese MDx market one of fastest growing in the world1
• Wondfo (SHE:300482) is a fast growing diagnostics leader in China with focus on POC2 testing, listed on Shenzhen Exchange (current market capitalization of USD ~1.3bn) with revenues in 2017 of ~ USD 160m
• Joint venture structure: 50%-50% ownership. Capital commitment of EUR 14m, split between parties and over several tranches
• Focus on local manufacturing, commercialization & registration with Chinese Regulatory Authorities of existing Idylla™ oncology assays
1 Source: DataMintelligence, “Global Molecular Diagnostics Market 2018-2025”2 Point of Care
• Commercialization agreement with Nichirei Biosciences1, announced on 7 January 2019, for the Japanese market, one of the largest MDx markets in the world representing around 10% of global MDx market2
• Successful registration of the Idylla™ Instrument and Idylla™ Console with the ‘Pharmaceuticals and Medical Devices Agency’ in Japan in October 2019
• Formal Idylla™ market introduction in November 2019
• In parallel, both partners are further progressing IVD- registration preparations for Idylla™ assays in Japan
Japanese go-to-market strategy
1 Part of Nichirei Corporation (TYO: 2871), a holding company with an annual turnover of ~¥ 550 billion 2 Source: MarketsandMarkets, 2015
21
• Located in Mechelen (Belgium), providing an additional annual capacity of over 1,000,000 cartridges
• Fully automated assembly workstations (versus a semi-automated on first line with an annual capacity of over 200kcartridges)
• Plastic parts manufactured with new multi-cavity molds (versus single cavity on first line)
• To support volume growth and cost effectiveness
22
Installed base x
Instrument utilization x
Average selling price = Sales
Key drivers• Commercial footprint• Commercialization
partnerships
Key drivers• Menu of tests• Regulatory
registrations
Key drivers• Reimbursement• Competitive advantage Gross margin driven by
• Volume• Manufacturing
automation
23
24
Commercial cartridge volume
Installed base
Partnerships
Menu of tests
Appointment new CFO
1 RoW = Rest of the World. RoW is defined as the world excluding European direct markets, US, China and Japan2 RUO = Research Use Only, not for use in diagnostic procedures3 An IVD companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Source: US FDA, last consulted on 7 April 20204 Developed in collaboration with Immunexpress5 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)30566-36 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])
Cash position
• Year-on-year Q1 growth of 68% in commercial cartridge volume demonstrating growth potential within well-established customer base across all regions
• Europe remains the largest contributor led by very strong performance in Northern, Central and Western European markets, partially fueled by pro-active stock orders in light of the COVID-19 pandemic
• Successful oncology partnership expansions with AstraZeneca: study on liquid biopsy testing using the Idylla™ ctEGFR Mutation Assay (RUO2), and with Bristol Myers Squibb Company (BMS): new project to pursue registration of Idylla™ MSI test as companion diagnostic3 (CDx) test in metastatic colorectal cancer (mCRC) in China
• Successful infectious diseases partnership expansion with Immunexpress for co-commercialization in Europe of SeptiCyte® RAPID Test on Idylla™, which recently received CE-marking
• A slower than expected installed base expansion across markets in Q1 2020 due to the global COVID-19 pandemic• Main impact suffered in Southern European, the US and RoW1 markets
• Development of Idylla™ SARS-CoV-2 test, the virus that causes COVID-19, for rapid & easy testing of individuals with flu-like symptoms• A unique potential in combination with recently CE-marked IVD SeptiCyte® RAPID Test4 on Idylla™ to identify patients with severe
disease, as recent data5 indicate that sepsis is the most frequently observed complication in COVID-196
• Appointment of Jean-Marc Roelandt as the new Chief Financial Officer (‘CFO’) of the Company as of 23 April 2020 • Senior executive with an established track record of +25 years as CFO in globally active publicly listed companies
• Biocartis’ cash position end Q1 2020 amounted to EUR 170.1m (unaudited figure)
973
337
1310
End 2018 Increase 2019 End 2019
133175
2018 Year-over-yeargrowth
2019
Installed base (in # instruments) Commercial cartridge volume (x 1,000)
+ 32%
~
• 337 Idylla™ instruments added in 2019, to a total installed base of 1,310 end 2019
• Slower than expected installed base expansion in Q1 2020 due to global COVID-19 pandemic, main impact in SouthernEuropean, the US and RoW markets
• During Q1 2020, US represented > 40% of new Idylla™ instrument placements but growth installed base slowed down due to COVID-19 impact
• Commercial cartridge volume increased to 175k in 2019, year-over-year volume growth of 32%
• Year-on-year Q1 growth of 68% in commercial cartridge volume in Q1 2020 demonstrating growth potential within a well-established customer base across all regions
• Europe remains the largest contributor led by very strong performance in Northern, Central and Western European markets, partially fueled by pro-active stock orders in light of the COVID-19 pandemic
251 RoW = Rest of the World. RoW is defined as the world excluding European direct markets, US, China and Japan
26
Europe RoW1
1 RoW = Rest of the World. RoW is defined as the world excluding European direct markets, US, China and Japan; 2 Wondfo is a fast growing diagnostics leader in China, listed on Shenzhen Exchange; 3 China is one of fastest growing MDx markets in the world. Source: DataMintelligence, “Global Molecular Diagnostics Market 2018-2025”; 4 Part of Nichirei Corporation (TYO: 2871). The agreement was announced on 7 January 2019; 5 PMDA = Pharmaceuticals and Medical Devices Agency in Japan. The Japanse MDx market is one of the largest MDx markets in the world, representing ~ 10% of the global MDxmarket. Source: DataMintelligence, “Global Molecular Diagnostics Market 2018-2025”
• European direct markets realized robust cartridge volume growthduring Q1 2020
• Predominantly driven by outperformance in Northern, Central and Western European markets
• Commercial cartridge volume growth in RoW distribution markets continued in Q1 2020
• Driven by increased use of Idylla™ on the existing RoW installed base
• Expansion installed base impacted due to COVID-19 disturbance in commercial activities of RoW distribution partners
• New market authorizations were also obtained for the Idylla™ MSI Test in Colombia and Canada and for the Idylla™ EGFR Mutation Test in Argentina
• During Q1 2020, the US represented over
40% of new Idylla™ instrument
placements
• Underlining the success of direct US sales
strategy
• The positive customer feedback resulted in
the attraction of new reference Idylla™
users that presented several Idylla™
posters & abstracts at the global USCAP
conference in March 2020
• Growth of both installed base expansion
and commercial cartridge volume stalled
due to the COVID-19 impact, as access to
hospitals and labs was restricted
US
27
• Jean-Marc Roelandt appointed as the new CFO of the Company as from 23 April 2020
• A senior executive with established track record of more than 25 years as CFO in globally active publicly listed companies
• With a focus on M&A, capital market transactionsand the implementation of adequate financial management infrastructure in dynamic and fast growing companies, he built up a solid expertise in various industries
• Prior to joining Biocartis, he was CFO of MDxHealth, a healthcare company that provides actionable genomic information to personalize the diagnosis and treatment of cancer
Additional details (in EUR 1,000)
Product sales revenue 2019 2018
Idylla™ system sales 6,220 4,185
Idylla™ cartridge sales 18,004 14,658
Product sales revenue 24,224 18,843
Collaboration revenue 2019 2018
R&D services 9,026 4,338
License fees 2,517 3,158
Milestones 908 833
Collaboration revenue 12,451 8,329
Breakdown total operating income
In EUR 1,000 2019 2018
Product sales revenue 24,224 18,843
Collaboration revenue 12,451 8,329
Service revenue 769 639
Total revenue 37,444 27,811
Grants and other income 288 840
Total operating income 37,732 28,651
28
Condensed income statement
In EUR 1,000 2019 2018
Total operating income 37,732 28,651
Cost of sales (21,328) (15,349)
R&D expenses (39,844) (36,842)
S&M expenses (18,011) (15,349)
G&A expenses (14,151) (7,971)
Total operating expenses (93,334) (75,511)
Operating result (55,602) (46,860)
Net financial result (7,934) (1,402)
Share in results of associates -631 0
Income taxes 99 109
Net result (64,068) (48,153)
Comments
29
• OPEX amounted to EUR 93.3m (y-o-y increase of 24%) in 2019 driven by higher:o COGS – increased product volumes & higher operational costs for
cartridge manufacturingo R&D expenses – increased depreciation & amortization charges,
employee benefit expenses and laboratory & cartridge costs. Partially offset by decreased facilities, office and a one-off impairment charge in 2018
o S&M expenses – increased due to additional operational expenses incurred in relation to the expansion of S&M team
o G&A expenses – increased due to overall organizational growth & a general cost allocation that is shifting more towards a commercial stage organizational structure
• Net financial result amounted to EUR 7.9m and included:o EUR 5.2m in relation to the Company’s convertible bond (of which
EUR 2.2m non-cash debt appreciation) o EUR 1.1m in relation to the repaid subordinated loano Commitment fees for the multiple purpose credit
• Net result equaled to EUR -64.1m in 2019
Condensed cash flow statement Remarks
• Cash burn from operating activities increased as result of:
o A higher operating loss for the period
o Increased investments in working capital
o Partial offset by increased non-cash adjustments
• Cash flow from investing activities included:
o Capital contribution made to China joint venture
o Capitalized Idylla™ systems and investments in laboratory & manufacturing equipment
• Cash flow from financing activities included:
o EUR 55.5m capital raise in January 2019
o EUR 150m convertible bond issue in May 2019
o EUR 23.7m repayments of borrowings (predominantly the Company’s subordinated loan)
• Net cash flow of EUR 115.3m, resulting in a cash position of EUR 179m as per end of December 2019
1. Excludes effects of exchange rate changes on the balance of cash held in foreign currencies2. Including EUR 1.2 million restricted cash related to KBC Lease financing
30
In EUR 1,000 2019 2018
Result for the period (64,068) (48,153)
Depreciation and amortization 9,719 4,273
Impairment losses 476 3,456
Working capital changes (48,788) (41,679)
Taxes & interests paid (5,466) (314)
CF operating activities (54,254) (41,993)
CF investing activities (5,496) (5,820)
CF financing activities (175,023) (1,507)
Total net cash flow1 115,274 (49,320)
Cash and cash equivalents2 178,726 63,539
Financial debt 166,578 35,335
31
• Due to the COVID-19 pandemic, new Idylla™ instrument placements slowed down towards end Q1 2020 as access to hospitals was restricted.
• As there is limited visibility on when these restrictions will be lifted and as Idylla™ instrument sales may temporarily further suffer from budgetary restrictions across all healthcare systems in the aftermath of the global pandemic, the Company is suspending its guidance on instrument placements in 2020 and will provide an update as soon as normal business activity resumes.
• Furthermore, Biocartis expects that this temporary slowdown may in turn moderate the growth of cartridge volumes during the second half of the year, although the expanded collaboration in infectious diseases with Immunexpress and the planned launch of a SARS-CoV-2 test on the Idylla™ platform could offset this impact.
• With this shift in product mix, Biocartis sees potential to still meet its 2020 commercial cartridge volume objective, however given current uncertainties around timing of normalization, the Company currently also suspends guidance on commercial cartridge volume growth.
• The cash position is still targeted to be in the range of EUR 110m by year-end 2020.
• US FDA 510(k) submission Idylla™ MSI Test o Together with partner Bristol-Myers Squibbo Subject to further feedback from US FDA interaction, expected by end 2020
• US FDA PMA2 application submission for Idylla™ RAS testso Together with partner Amgeno Timing under assessment
• Further development of the Idylla™ GeneFusion Panel towards expected launch by end 2020 (RUO1)
1 RUO = Research Use Only, not for use in diagnostic procedures2 PMA = Pre-Market Approval
TestArea
Subject to change
32
8 May 2020 Annual and Extraordinary General Meeting Biocartis Group NV
3 September 2020 H1 2020 results
12 November 2020 Q3 2020 Business Update
33
After the summer of 2020, Biocartis will organize a Capital Markets Day for financial analysts, media & institutional investors to provide an update of its Idylla™ product strategy (date to be confirmed)
Shareholder overview (as per 12 December 2019) 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 & Scott Bardo
New analyst TBC
Thomas Guillot
Lenny Van Steenhuyse
Alexandru Cogut
Kris Kippers
34
Shareholder >3% table # shares % shares
Invesco, Ltd. 6,969,077 12.4%
Johnson & Johnson Innovation 5,481,128 9.7%
Debiopharm Innovation Fund 2,750,304 4.9%
ParticipatieMaatschappij Vlaanderen NV (Flemish Region) 2,342,345 4.2%
Other institutional and retail investors 38,839,234 68.9%
Total outstanding shares (non-diluted) 56,382,088 100.0%
Appendix
35
• 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
36
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
37
Cancer-specific applications Pan-cancer applications
Comprehensive actionable 1st-line menu in 2-cartridge format allows for higher market shares and gross margins
2-cartridge menus for current cancer markets
• Enhanced development capabilities allow for higher number of targets in one Idylla™ cartridge
• Opportunity to offer actionable 1st line menus based on two Idylla™ cartridges only:
CRC1
menu
1. EGFR/BRAF+ (DNA-based)2. GeneFusion (RNA-based)
1. KRAS/NRAS/BRAF2. MSI
Lungmenu
New areas
• Development of new tests for additional cancer types e.g.:
o Breast cancer
o Gastric cancers
o Hematological cancers
• Validation existing menu for additional sample types
• Core tests of cancer-specific menu are applicable for pan-tumor applications
Idylla™ cartridge
• KRAS/NRAS/BRAF
• MSI
• GeneFusion (NTRK)
Select potential applications
• Breast, endometrial, cervical
• Gastric, prostate, endometrial
• Gastro-intestinal, breast
Efficient access to pan-tumor setting (validation of existing menu)
Indicative, subject to change
1. CRC = colorectal cancer.38
Growth in emerging therapeutic areas. Address testing needs of major immuno-therapies and leverage menu toward pan-cancer applications
Immune checkpoint inhibitorsPrevent tumor from hiding from the immune system
Cell therapyDeploy immune cells designed to fight cancer
• Immune cells can fight cancer
• Cancers can hide from immune cells
• Immune checkpoint inhibitors such as Keytruda®1 prevent this hiding
• Such inhibitors often act pan-cancer
• Immune cells can be specifically selected or engineered to fight cancer
• To date, cell therapies have proven successful in hematological cancers
• Clinical trials ongoing also for solid cancers
Idylla™ for immune checkpoint inhibitors
Idylla™ addressable immunotherapy segments
Idylla™ for cell therapyIdylla™ for both major therapeutic classes
Idylla™ MSI test
• May be validated for immunotherapy (i.e. immune checkpoint inhibitors) selection
• Initial focus on CRC immunotherapy
• Pan-cancer validation in the future
Idylla™ Hot-Cold signature
• Is the immune system already fighting this cancer? Does it need to be enabled?
Idylla™ immunotherapy resistance test
• Is the tumor resistant to immunotherapy?
Idylla™ test(s) for patient management
• Cell therapies are highly successful
• Therapy cost (e.g., hospitalization) and side effects create high need for rapid patient management around treatment
Indicative, subject to change
1. Marketed by Merck.
Cancer Cell
PD-1PD-1 Antibody
PD-L1 Antibody
PD-L1T-Cell
Cancer CellAntigen
Chimeric
Antigen
Receptor
CAR-T Cell
39
1. MRD = Minimal Residual Disease. 2. CML = Chronic Myeloid Leukemia.
Liquid biopsy testing
• Access genetic tumor information via liquid samples:o Bloodo Urine o Saliva
• Advantages over solid biopsy testing:o Less invasiveo Less expensiveo Less sampling biaso More repeatableo Real-time mutation status
• Improved detection of low burden disease:o Earlier and more accurate than current
protein tests; earlier than imagingo Advantage for MRD1, recurrence
monitoring
Idylla™ liquid biopsy and monitoring menu
Cancer care continuum
Diagnosis
Treatment Start
Treatment Stop
Relapse
Pre-diagnosis• Inherited risk• Screening / early detection
Pre-therapy• Prognostics / stratification• Therapy selection
On-therapy• Response monitoring• Resistance monitoring
Post-therapy• Post-therapy MRD1
• Recurrence monitoring
Recurrence• Therapy selection• Recurrence management
Menu focus
1
Therapy selection• Liquid biopsies complement solid biopsy menu• Focus: if tissue not available at diagnosis or at progression
Response monitoring and post-therapy MRD1
• Focus: applications that require Idylla™ speed and are backed by growing evidence of clinical utility:• On-therapy monitoring • Post-treatment MRD1
• Population: Mid and late stage patients across most cancer types
Recurrence monitoring• Focus: on hematological cancers (e.g., CML2) as these are
established markets (i.e. guidelines inclusion)• Population: long-term therapy and recurrence monitoring
1
1
2
23
A high volume menu for repeat-testing applications that require Idylla™’s unmatched turn-around-time. Address testing needs across early & late stage cancers for a range of major cancer treatments.
Access new customer base: hemato-oncologists & blood testing laboratories
Indicative, subject to change
40
1
2
3
• Focus on oncology tests
• Clinically validated contento Increases barrier to entry for
competitors
• High clinical utility and reimbursement
o Provides attractive pricing and fast market adoption
• High volume applicationso Large addressable populationo High market share potentialo Repeat testing
• Growing number of testso Driven by genomic discovery and
validation efforts over past decade
• Broad range of testing applicationso Prognostic, risk stratification,
screening tests, etc.o Tests are generally cancer-specific
• Diverse cancers and sample typeso On-market or in development for
many solid and hematological cancerso Solid & liquid samples
• Additional cancer franchiseso Complementary menu (e.g. breast
cancer)
• Expansion into new customer segments o General oncology o Oncology sub-specialties within
urology, dermatology, hematology…
• Broader commercial footprinto Commercialization supported by sales
network partner
• Development mainly partner-funded
Market landscape Test selection criteria Idylla™ opportunity
• Market leader in breast, urology cancer
• Breast: launch 2020
• Urology franchise opportunityo Initial focus on prostate cancer
• Biocartis development partner Clinically validated High reimbursement Attractive volumes
Example collaboration Exact Sciences (formerly Genomic Health)
Indicative, subject to change
Complementary menu with proprietary high value & volume tests, with a focus on existing & potentially additional customer segments
41
Biocartis Investor RelationsGeneraal de Wittelaan 11 B
2800 Mechelen
BELGIUM
tel. +32 15 63 17 29
www.biocartis.com
42