Investor Day - Genomic Vision › ... › Genomic-Vision-Investor... · Erwan Martin, MBA CFO •...
Transcript of Investor Day - Genomic Vision › ... › Genomic-Vision-Investor... · Erwan Martin, MBA CFO •...
Investor Day23 March 2016
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Disclaimer
Today’s speakers
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Aaron Bensimon, PhD
Founder, President, CEO
• Co-inventor of Molecular Combing Technology
• Degree in Molecular Biology; PhD of Weizmann Institute
• Head of Genomic Stability Unit at the Pasteur Institute
Erwan Martin, MBA
CFO
• Previously with Cytomics Pharmaceuticals (CFO) and Syndex (French audit company)
• Degree in Business Administration
• Joined Genomic Vision in 2009
Stephane Altaba, MBA, PhD
VP Corporate Development
• PhD in Biotechnology (ENSAIA) and MBA (ESCP Europe)
• Over 20 years of experience on strategic positions within the pharmaceutical sector including 12 years with Sanofi
• Joined Genomic Vision in 2015
Dr Jean-Baptiste Vannier, PhD
Leader of the Telomere Replication and Stability Group
• MRC Clinical Sciences Centre
• Faculty of Medicine, Imperial College London
Genomic Vision at a glance
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• Molecular DX company developing tests and essays on Molecular Combing platform in two commercial markets:
— In Vitro diagnostics (IVD) for genetic diseases and cancers
— Life Sciences Research Tools (LSRT)
• Strategic alliance with Quest Diagnostics formed in November 2010 and renewed in February 2015
• Robust pipeline of 5 tests with CombHelix FSHD test commercialized since 2013 in Europe / US and BRCA Combing test scheduled for launch in 2016
• Significant opportunity in rapidly growing oncogenetic testing market, projected to grow to $10B -$25B by 2020, with Prediction/Detection tests expected to account for 56% of the total (Bloomberg and BoozAllenHamilton)
• Solid portfolio of more than 130 patents
• Multiple value-creating milestones in 2016
GV history
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Co-development agreement with the Assistance Publique -
Hôpitaux de Marseille 2006
CombHeliX FSHD test CE marked
2013
Strategic alliance with Quest Diagnostics
2010
Renewal of alliance with QD until 2018
2015CombHeliX FSHD test commercialized in QD
2013
IPO on Euronext Paris, €25.8m raised
2014
Company was created as a spin-off from Institut
Pasteur2004
Molecular CombingTechnology
Our panoramic Genomic Vision
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New ways to visualize structural variations and dynamic genomic events
Point Mutations Structural Variations and Copy Number Variations
Chromosomic aberrations
1bp - 2kbp 3 kbp – 1Mbp 2Mbp - Gbp
Sequencing FISH
ATGC ATCC
MOLECULAR COMBING
Direct visualization
Regions of interest
The gene and its environment
Vinyl Silane coated glass surface immersed in a solution of patient DNA
DNA molecule attached and stretched over the glass surface in parallel. 5 minute process
Hundreds of copies of combed DNA molecule from a single patient allowing quantitative analysis.
• DNA is extracted using standard kit based methods or from agarose imbedded cells.
• Extracted DNA is stretched across and attached to a vinyl silane glass surface by simple immersion and withdrawing of the coverslip from the DNA solution.
Molecular Combing: The Technique
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The DNA combing is automatized thanks to GV technology and takes 5 minutes
Genomic Vision’s technology workflow
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From DNA purification to data output…
Extraction GMC hybridization Imageacquisition GMC analysis
1 2 3 4 5
Combing
FiberPrep®
DNA Extraction KitFiberProbes®
Genomic Morse Code setFiberVision®
Automated ScannerFiberStudio®
Analysis Software
FiberComb®
Molecular Combing System
Sample from:BloodTissueCell cultures
Genomic Vision’s competitive environment
Sources: Genomic Vision; Pacific BiosciencesNote: (*) Copy Number Variation and Structural Variation. 10
3rd Generation Sequencing
FISH
Molecular combing, Digital count and Nanochannel
Direct detection
Structural Variations and Copy number variations
Chromosomal aberrations
PCR and NGS
Indirect detection (fragmentation
and amplification)
CGH and MLPA
Small mutations
GV is well positioned in the SV and CNV segments, with a relatively low number of competitors
2015 financials
- Combicoverslips®- FiberPrep®- Reservoir- Carriers
- FiberComb®- FiberVision®
Hardware sales Consumable sales Partnering revenues
- R&D funding- Royalties
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GV Business Model: multiple revenue streams
P&L
In € thousands - IFRS 31.12.2015 31.12.2014
Revenue from Quest Diagnostics R&D collaboration 2,069 3,218
Product Sales 291 237
Total revenue from sales 2,360 3,455
Other revenue 1,957 1,438
Total revenue from activity 4,317 4,893
COGS -106 -55
Research & Development -4,224 -4,353
Sales & Marketing -1,222 -432
General & Administrative -3,171 -2,268
Other 14 1
Net operating expenses -8,708 -7,107
Operating profit / loss -4,391 -2,214
Pre-tax profit / loss -4,338 -2,156
Net profit / loss -4,338 -2,156
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Balance sheet
In € thousands - IFRS 2015 2014
Cash & cash equivalents* 15,593 22,764
Non current assets 3,084 1,314
Current assets 3,261 2,365
Total assets 21,937 26,444
Shareholders’ equity 18,383 22,695
Non current liabilities 260 309
Current liabilities 3,295 3,439
Total liabilities 21,937 26,444
* o/w €147 thousand in pledged mutual funds
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Strong cash position as of Dec. 31, 2015: € 15,6m vs. € 22.8m on Dec. 31, 2014
Cash flow statement
In € thousands - IFRS 2015 2014
Cash flow from operating activities -5,535 -3,771
o/w free cash flow -4,645 -1,898
o/w change in Working capital need -890 -1,873
Cash flow from investing activities -1,573 -623
Cash flow from financing activities -63 23,932
Effect from exchange rate changes 0 0
Net change in cash -7,170 19,538
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2015 key achievements
A. BENSIMON CEO
QualitySystems Manager
M. GARCIA
Cial & Marketing Director
D. DEL BOURGO
Bio-IT DirectorI. KYRGYZOV
T&I DirectorY. GHOMCHI
RPD DirectorS. BARRADEAU
Biomedical ReseachDirector
A. JACQUET
US Strategy DirectorJ. HANLEY
IPD. BERNEMAN
ICQ ManagerC. THIBERVILLE
HRM. GORDIEN
CFOE. MARTIN
VP CorporateDevelopment
S. ALTABA
VP R&D C. CHYPRE
3 major recruitments in 2015:
• M. Stéphane Altaba, PhD., is appointed Vice-President Corporate Development
• M. Camille Chypre, PhD., is appointed Vice-President R&D
• Mrs. Anne Jacquet, PhD., is appointed Medical Director17
Senior management team reinforced through a number of strategic recruitments
R&D funding1
• Payment to GV of R&D milestones
• Development of lab-developed tests (LDTs) used by Quest
Commercial license2
• GV has granted to QD an exclusive license for commercializing in the US:
– FSHD test: launched in August 2013
– BRCA test (to be launched Q4 2016)
– HNPCC test (to be launched in 2017)
– SMA (clinical study to be completed early 2017)
• High teens royalties
Equity investment3
• 13.8% stake in Genomic Vision post-IPO (21.3% pre-IPO)
• 1 Board member
• Strategic alliance with Quest Diagnostic signed on November, 2010 • Partnership renewed in 2015 for 3 additional years until November 2018 in advantageous terms:
– GV has the right to develop and market new tests with other partners, including in the USA
– Substantial increase in royalty rate
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Quest: strengthened strategic partnership for GV in the US
Strategy execution according to plan
February2015
Renewal of the strategic
collaboration with Quest Diagnostics for
3 more years
June 2015
Selection in the Horizon 2020
program’s ‘BeyondSeq’ project
December 3,2015
Strategic Partnership with the Imagine
Institute, Europe’s Largest Genetic
Research and Care Cluster
October 2015
Completion of the new combing
platform (high-throughput scanner +
new software + automatic DNA
extractor) at Quest Diagnostics
Clinical partnership with Rouen
University Hospital for the SMA
diagnostics test development in
France
Launch of a Clinical Study with Reims
University Hospital to Establish New
Screening Tool for Early Detection and
Prevention of Cervical Cancer
December 14,2015
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Achievement of all key milestones planned for 2015
Automatic DNA extractor: Runs 48 samples in parallel
High-throughput scanner: Reduction of the time ofimage acquisition from 6 hours to 1 hour
New software for the image analysis: validated on HNPCC test
Available for the LDT development of all jointly developed tests
Installed at Quest Diagnostics
Strategic partnership aiming to:- identify pathologies caused by
structural variations- contribute to the creation of new
genetic tests for GV’s portfolio
Installed at Institut Imagine
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The new combing platform installed at Quest and Institut Imagine
Platform efficiency improved to meet the requirements of large scale genetic testing & top level life science research
SMA combing test: improvement of the genetic counselling by identifying a sub-population of SMA carriers
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Genomic Vision’s objectives:
- Identification by Molecular Combing of a biomarker associated with the “2+0” structural variation
- Development of a clinical diagnostics test to identify “2+0” carriers
Spinal Muscular Atrophy • Autosomal recessive disorder due to homozygous loss of functional SMN1 protein
• 1 million to 1.5 million healthy carriers in Franc, 8% of them going undetected by tests currently available
• 2nd most frequent neuromuscular child disease after Duchenne with incidence of 1/6,000 - 1/10,000 births
International partnerships and entry into clinical development
• The SMN locus, poorly characterized by sequencing, was precisely mapped by molecular combing
• BADGES study (NCT02550691) in collaboration with the Rouen University Hospital
• A Pilot study with Quest Diagnostics with samples from African-American cohort
• Participation in ‘BeyondSeq’, a European’s Commission project within the framework of the Horizon 2020 program
Centromeric copy Telomeric copy
SMN2
SMN1
500Kb 500Kb
CNV
HPV combing test: a “game changer” and un-partnered asset
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ROUTINE PAP-SMEAR
Pos
Wait 1 yearRedo pap-smear COLPOSCOPY
Clear cutresults
Ambiguous results
HPV TestHPV +
NegHPV Combing
Test
HPV -50% 50%
HPV Combing test to avoid invasive and expensive colposcopies
• Detection of HPV integration
• Distinguishes high-or low-risk patients
• Avoids useless invasive colposcopies
Cervical cancer
• Cervical cancer is the third most common cancer among women
• Almost 100% of patients with cervical cancer are positive for HPV
• 90% are transient, the persistence is usually accompanied by the integration of the HPV
50% of women tested positive with a conventional HPV test do not require colposcopy
HPV tests
Nb. of colposcopies per year
56.3 million
4.1 million
67.5 million
3.4 million
ESTIMATED SCREENING MARKET
HPV clinical study underway
• Clinical study started at Reims University Hospital to Establish New Screening Tool for Early Detection and Prevention of Cervical Cancer
• The Largest Study ever Undertaken Using the Molecular Combing Technique on 3,500 Patients at 11 French Hospitals
BRCA combing test: a potential blockbuster for BRCA large rearrangements detection
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• Test validation by Quest Diagnostics in 2015
• LDT development started at Quest Diagnostics’ Nichols Institute for commercial launch in 2016
• Clinical utility and positioning study in Europe and the USA to support marketing and reimbursement of the test, to be completed in Q4 2016
Test development on track for a hard launch in 2016
• 5% - 10% of breast cancer cases are familial inherited
• HBOC risk increases dramatically in the presence of mutations in BRCA1 and BRCA 2 genes
• 10% - 15% of BRCA mutations are Large Rearrangements (LR)
Hereditary Breast and Ovarian Cancer (HBOC)
Detection of point mutations in BRCA genes by sequencing
Detection of LR in BRCA genes
Patients and people with strong family historyBRCA combing test enables detecting new LR in BRCA genes
BRCA combing test added values:
• Detection of all balanced rearrangements
• Covers exon and non-coding regions
• Accurate visualization hard to sequence regions
Molecular Combing
Strategic development in In Vitro Diagnostics (IVD)
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BRCA
HPV & SMA
• 1st test commercialized
• Rare disease
• Hereditary predisposition
• High risk population
• General screening
• Large population testedEarly-detection tests
Predisposition tests
Confirmation tests
HNPCC
FSHD
Potential patient population
Proof of concept
Blockbuster
Game Changer
Genomic Vision’s Pipeline in IVD
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Identification of target genes/biomarkers
GMC development Clinical evaluation CE marked
FSHD
BRCA
HNPCC
HPV
SMA
LAUNCH
2013
2016
2017
2018
Clinical study validated in 2017
Strategy
Market addressed by Genomic Vision
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Life Sciences Research Tools (LSRT)In Vitro Diagnostic (IVD)
• DNA replication analysis
• Genetic abnormalities
• Biomarker discovery
• Gene editing control
Genomic Vision: 1 technology, 2 market segments
2
T
Screening
• SMA* (Spinal Muscular Atrophy)
Carrier Screening
c. $800 M** Total addressable market c.$700 M*** Current products **for US & 3 EU (FR, UK, DE) markets; Source: Company
Predisposition
Diagnostic
• HPV* (Human Papilloma Virus)
• BRCA1 & BRCA2* - HNPCC*
• FSHD*
1
Hospitals, Reference centers Biopharma, Translational research
Life Sciences Research Tools: a promising market for GV
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“Molecular Combing of Single DNA Molecules on the 10 Megabase Scale”Nature review’s Scientific Reports, The Nobel Prize M. Paul Nurse, 2016
0
500
1000
1500
2000
2500
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Norio P.and Schildkraut C.L. (2001) Science 294, 2361-2364
Herrick J. et al. (2002) J. Mol. Biol., 320, 741-750
Key publications on combing technologyapplied to DNA replication (1999-2002):
“DNA replication” and “fork” and “eukaryote” “DNA replication” and “fork” and “combing”“combing”Market potential and target audience for GV DNA combing technology ** :
• Core target: over 600 labs working on DNA replication using combing
• …plus additional 1600 labs working on DNA replication
Nb. of publications*
“DNA replication”Strong and constant increase in DNA replication publication(CAGR: +6% between 1996-2016)
“Combing”Strong and constant increase of “combing” citation in the literature (CAGR: +17% between 1996-2016)
“DNA replication & Combing”In 2013, 28% of publications on DNA replication mentioned combing method (vs 7% in 1996)
2210
1120
629
Herrick J. and Bensimon A. (1999)Biochimie 81, 859-871
* Source: Google Scholar, March 2016 ** Assumption: 1 publication per lab
DNA Combing is widely adopted by the Scientific Community as the technology of choice in DNA replication studies
• Leveraging our expertise on the diagnostics market to serve Life Sciences Research Tools customers: - Core facilities
- Biopharmaceutical industry
- Academic research lab
New partners /customers
• The placement of GV’s technology platform in research and pharma laboratories will lead to discoveries with high potential to be commercialized as IVDs or lead to the development of companion diagnostics with long-term potential for royalties and other revenue-generating opportunities
Long-term IVD development potential
• Need for an automated and complete DNA combing platform:
- Reduce the time of workflow
- Enable to focus on results interpretation
Strong demand for a standard solution package
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Life Sciences Research Tools opportunity rationale
Maximizing the potential of Molecular Combing technology
What?RCA consist of analyzing rate of fork movement and fork density on replicating DNA fibers
To Whom?GV’S RCA technique can provide unique information on DNA replication dynamics used in:• Biopharma in drug development (anti-cancer drugs,…)• Translational Research• Academic research
Why?Need for standardization and automation
Addressable markets :• 1000 laboratories worldwide• $50-$100 MM*
GV’s goal : Make RCA technique the gold standard in Replication providing • Automated high resolution digital images (Easyscan ® service and Fibervision®) • Accurate Signal detection and analysis (proprietary dedicated software)
RCA principle: Dual-pulse labelling of the replicating DNA with modified nucleotides
* Source: Company 30
Replication Combing Assay (RCA)
What ?GMC on demand offers the possibility to visualize content and a potential multi-gene analysis on large genomic regions
To Whom ?• Clinical research labs• Core facilities (genetic association studies)• Biopharmaceutical industry
Why?Strong demand for turnkey solutions ready to use
Addressable markets :• 7000 laboratories WW• $350-$400 MM*
GV’s goal• Raise awareness among core facilities and clinical labs and create new collaboration• Develop new FiberVision® applications in IVD to provide GV’s portfolio with new tests
GMC design tool
Customers
Loci of interest
Relationship Promotion
Probes design and manufacturing
GMC detection software
* Source: Company 31
Genomic Morse Code (GMC) on demand
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Imperial College London – Business Case Dr Jean-Baptiste Vannier, PhD
• Epigenetics - Telomere replication and Stability group leader (2014 – Today)
• European Research Council Starting Grant award
Fields of Research• Cellular response to replication stress
• Enzymatic activity resulting in telomere replication aberrations
Molecular Combing technology of choice:
• Direct visualization of telomere abnormalities
• Replication fork dynamics (stability / speed / origin firing)
• Post Doc at Cancer Research UK (2009-2014)
Vannier et al. (2013)Science 11;342(6155)
Molecular Combing
Modified Genomes
Quality control
Delivered DNA fragment
Genome
Cas 9
What?GV Molecular Combing technology provides an optimized quality control tool for high-confidence gene editing
To Whom?Gene Editing companies e.g.:• Designing pathogen resistant crops• Therapeutic correction of defective genes responsible for the diseases
Why?• New applications for quality control / companion tests
that currently does not exist• Strong demand observed at industrial level
Market:• CRISPR/Cas9 will account for the largest and fastest growing segment• Over $1 billion USD of venture-capital financing invested in emerging gene-editing technologies
within the past two year
GV’s goal• Become the partner of choice of Gene Editing company to evaluate the intactness of the
target genetic loci after genome editing
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Gene editing quality control (GE)
Advocating technology
Reference Technology in LSRT
RCA
Biomarker discovery
• A customer oriented structure
• RCA - GMC test developed
• GV technology widely used in main LSRT facilities
• Key partnership development around biomarker and gene editing control
Sales to core labs and Biopharma and key partnership
Sales to academic partners
Individual labsLe Lab
RCA GMC
Gold StandardGMC
Market potential
Gene Editing control (GE)
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Strategic development in Life Sciences Research Tools (LSRT)
New territory for value creation by both near-term revenues and long-term growth potential
2016 – Pre-Marketing 2017 – Full Launch
• Promote Genomic Vision as the inventor and expert of Molecular Combing
• Create an international advisory board
• Stimulate the existing market (new offerings)
• Generate comparative studies to convince the users of combing-like technologies
• Generate testimonials- whitepapers
• Launch FiberVision® Scanner V1.2: provide a solution that meets Life Science research market through a more compact, easier to use and less expensive scanner
• Launch of FiberStudio RCA: provide an automated detection and analysis software
Leverage our established reputation in the field to generate new interests and boost our customer base
• IMAGINE conference: communicate around the applications in particular replication studies
• Trieste: DNA replication meeting : promote GV technology to DNA replication experts and organization of an event
• AACR: GV’s booth. Increase our visibility towards major cancer research centers in the world
• Festival of Genomics: take advantage of this scientific exhibition to exchange with KOL in genomic fields and find new opportunities
• Concretize our offer with a new range of products
• Add features with counterstaining and locus specific assessment
• Enlarge our KOL network
• In addition to the academic centers, generate new interests in the biopharmaceutical industry
Provide innovative and affordable solutions to expand our influence in the DNA replication institutions
• Full Marketing Launch
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DNA Replication: Key milestones for product launch
Execution
HPV New indications
License to new potential partners
Licensing to CLIA* laboratoriesRevenues: Royalties
Exclusive license
FSHD, BRCA, HNPCC, SMA
US: a key market for Genomic Vision
LSRT
Direct salesInternal sales force
Partnering
“Individual“ labsReagents sales + EasyScan service
“Core Facilities”Instrument + Reagents sales+ Maintenance
IVD
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Commercial plan – United States
IVD LSRT
EU: GV’s domestic market
Direct salesPartnering
Hospitals, reference labs, medical research labs
Specializedlabs
Collaboration and license to an industrialpartner
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Commercial plan – Europe
Direct salesInternal sales force
Partnering
“Individual“ labsReagents sales + EasyScan service
“Core Facilities”Instrument + Reagents sales+ Maintenance
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GV’s main collaborations worldwide
Identification of target genes/biomarkers
GMC development Clinical evaluation CE marked
FSHD
BRCA
HNPCC
HPV
SMA
RCA
GMC
In Vitro Diagnostic (IVD)
Life Sciences Research Tools (LSRT)
Product design Development of the product
Research Labs collaboration
IndustrializationCommercialization
GE
* Companion diagnostic
Launch
2013
2016
2017
2018
Clinical study validated in 2017
Launch
2016
2017
TBD 40
Solid and diversified pipeline with near-term value creation
Several milestones in 2016
RCA
4
• Launch of RCA to research and pharma laboratories
SMA test(carrier screening)
3
• Results of the proof-of-concept study with CHU Rouen
BRCA test(breast cancer predisposition)
• Launch by Quest Diagnostics
2
Adoption by key Hospitals in
EU & US
• Establishment of the molecular combing platform in new diagnostics centers for FSHD and BRCA testing
1
StrategicPartnership
5
• Key partnership with a major player in IVD and/or LSRT
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Investment Highlights
• Solid position in the IVD market with a robust pipeline of tests for genetic diseases and cancers
• Extension of value creation to the rapidly addressable LSRT market:- Strong recognition of molecular combing by the Scientific community- Increased demand for standardized solutions in replication and gene editing
• Overall addressable market of $1.5bn worldwide
• Diversified revenue streams: - Hardware sales- Consumable sales - Partnering (royalties & R&D Funding)
• Top-level management team with complementary skills to execute the strategy
• Multiple value-creating milestones in 2016
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Thank you. www.genomicvision.com
Contacts
Genomic Vision
Aaron Bensimon – CEO / Erwan Martin – CFO
Tel: +33 1 49 08 07 40
E-mail: [email protected]
Investor Relations & Strategic Communications
Anne Marie Fields (U.S.)
Tel: 212-838-3777
Email: [email protected]
Emmanuel Huynh / Dusan Oresansky (EU)
Tel: +33 1 44 71 94 92
E-mail: [email protected]
Appendix
• High: €15.86 (March 2nd, 2015)
• Low: €8.50 (January 5th, 2016)
• Number of shares: 4,457,734
• Market Cap: €34.4m (March 22nd, 2016)
• Average daily trading: 6,413 shares since the IPO
Shareholding structure (As of 31.12.2015)Stock market information
10,1%
3,6%
13,8%
36,3%
36,1%
0,2%Management, founders & employees
Institut Pasteur
Quest Diagnostic
Free Float
Vesalius Biocapital
Autocontrôle
45
Genomic Vision & The stock exchange