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Investor PresentationNovember 2015
A pioneering approach
for genomic analysis
DISCLAIMER
• This document has been prepared by Genomic Vision (the "Company") and is provided for information purposes only. This document does not purport to containcomprehensive or complete information about the Company and is qualified in its entirety by the business, financial and other information that the Company is requiredto publish in accordance with the rules, regulations and practices applicable to companies listed on Euronext Paris. No reliance may be placed for any purposeswhatsoever on the information or opinions contained in this document or on its accuracy or completeness.
• This presentation does not constitute an offer to sell, a solicitation of, or an invitation to subscribe for or to buy, securities of Genomic Vision in any jurisdiction
• The information and opinions contained in this document are provided as of the date of this document only and may be updated, supplemented, revised, verified oramended, and thus such information may be subject to significant changes. The Company is not under any obligation to update the information or opinions containedherein which are subject to change without prior notice.
• The information contained in this document has not been subject to independent verification. No representation, warranty or undertaking, express or implied, is made asto the accuracy, completeness or appropriateness of the information and opinions contained in this document. The Company, its subsidiaries, its advisors andrepresentatives accept no responsibility for and shall not, under any circumstance, be held liable for any loss or damage that may arise from the use of this document orthe information or opinions contained herein.
• This document contains information on the Company’s markets and competitive position, and more specifically, on the size of its markets. This information has beendrawn from various sources or from the Company’s own estimates which may not be accurate and thus no reliance should be placed on such information.
• This document contains certain forward-looking statements. These statements are not guarantees of the Company's future performance. These forward-lookingstatements relate to the Company's future prospects, developments and marketing strategy and are based on analyses of earnings forecasts and estimates of amountsnot yet determinable. Forward-looking statements are subject to a variety of risks and uncertainties as they relate to future events and are dependent on circumstancesthat may or may not materialize in the future. Forward-looking statements cannot, under any circumstance, be construed as a guarantee of the Company's futureperformance and the Company’s actual financial position, results and cash flow, as well as the trends in the sector in which the Company operates, may differ materiallyfrom those proposed or reflected in the forward-looking statements contained in this document. Important factors that could cause actual results to differ materially fromthe results anticipated in the forward-looking statements include those discussed or identified in the “Risk Factors” section of our Base Document registered with theAutorité des marchés financiers on March 3, 2014 under number I.14-005 (a copy of which is available on www.genomicvision.com). Even if the Company’s financialposition, results, cash-flows and developments in the sector in which the Company operates were to conform to the forward-looking statements contained in thisdocument, such results or developments cannot be construed as a reliable indication of the Company's future results or developments. The Company does not undertakeany obligation to update or to confirm projections or estimates made by analysts or to make public any correction to any prospective information in order to reflect anevent or circumstance that may occur after the date of this document.
• Certain figures and numbers appearing in this document have been rounded. Consequently, the total amounts and percentages appearing in the tables may notnecessarily equal the sum of the individually rounded figures, amounts or percentages.
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2November 2015
A pioneering approach
for genomic analysis
KEY MANAGEMENT TEAM
3
Aaron Bensimon, PhD
Founder, President, CEO & CTO
• 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
Vice President Finance & Corporate Development
• Previously with Syndex (French audit company) and CFO of CytomicsPharmaceuticals
• Degree in Business Administration
• Joined Genomic Vision in 2009
November 2015
A pioneering approach
for genomic analysis
INVESTMENT HIGHLIGHTS
4
• Molecular diagnostics company developing tests for
genetic diseases and cancers based on molecular combing
• Strategic alliance with Quest Diagnostics formed in November 2010 and renewed in February 2015
• First test commercialized since 2013 in Europe and
US
• Robust pipeline with 2 major tests scheduled for launch in 2015 and 2016 respectively
• 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 130 patents
November 2015
SOLID POSITION IN RAPIDLY GROWING ONCOGENETIC TESTING MARKET
1
A pioneering approach
for genomic analysis
MOLECULAR COMBING DETECTS STRUCTURAL VARIATIONS
6
Scale: Large Multi Gene
(3Kbp-1Mbp)
Scale: Chromosome
(1Gbp)
Sequencing
Point Mutations (SNPs)
Scale: Single Gene
(1bp-2Kbp)
Sickle Cell AnemiaCharacterized by point mutation
BRCA2 normal gene
BRCA2 mutated gene
Breast Cancer (BRCA2)Characterized by a large insertion in BRCA2
gene
Trisomy 21 –Down Syndrome
Characterized by three copies of chromosome 21
Molecular Combing
Structural Variations
Fish (1)
Chromosomic aberrations
Notes: (1) Fluorescent in situ hybridization.
November 2015
A pioneering approach
for genomic analysis
THE IMPORTANCE OF DETECTING STRUCTURAL VARIATIONS
What are structural variations?
Detecting structural variations dramatically improves clinical diagnostics & prognosis
Most technologies cannot accurately detect structural
variations, corresponding to large genomic
rearrangements (LRs) in the 10Kbp – 1Mbp scale range
Structural variations Scientific evidence
Structural variations (SVs) have a strong clinical impact
as they are involved in many diseases
• Using Molecular Combing, Dr. Dominique
Stoppa-Lyonnet has detected large genomic
rearrangements representing 15% of
BRCA 1 samples that weren’t detected with
Myriad Genetics sequencing.
• Large rearrangements in the BRCA1 and
BRCA2 genes represent 10% to 20% of
the mutations directly responsible for cases
of hereditary breast cancer cases each year.
7November 2015
MOLECULAR COMBING: PROPRIETARY AND CLINICALLY-VALIDATED TECHNOLOGY
2
A pioneering approach
for genomic analysis
UNIQUE PROPRIETARY TECHNOLOGY
Applying morse code to the genome to enable clearcut diagnostics interpretation
• A fluorescent barcode along the combed DNA molecules automatically identifies and interprets complex, often hidden, structural variationsGenomic
MorseCode
2
BRCA2 normal gene
BRCA2 mutated gene
10kb
Treated glass surface immersed in a solution with naturally-occuring DNA molecule
Single DNA molecule attached and streched on the glass surface
Hundreds of copies of combed DNA molecule from a single patient allowing quantitative analysis
Molecular Combing
1Extracting and stretching single DNA molecule
• DNA is stretched across and attached to a specially-treated glass surface
• User-friendly technology for single-molecule analysis of patient DNA
9November 2015
A pioneering approach
for genomic analysis
COMPREHENSIVE OFFERING: PLATFORM AND PRODUCTS
Genomic Vision’s platform
Molecular Combing System
Scanner
Hybridizers
CombHeliX® FSDH Software
Genomic Vision’s consumables
CombHeliX® FSDH probes
Silanized coverslips
DNA Extraction kits
Disposable reservoirs
10November 2015
A pioneering approach
for genomic analysis
FULLY INTEGRATED AND PROTECTED WORKFLOW
Initial IP filed by Aaron Bensimon’s team at Institut Pasteur
FROM TO
Combing Image Acq.
HybridizationExtraction Image Anal.
11
Robust, 130-patent portfolio supporting all steps of the Genomic Combing workflow:
Extraction, Combing, Hybridization and Image Acquisition and Analysis
November 2015
A pioneering approach
for genomic analysis
GENOMIC VISION’S TECHNOLOGY
12
• The molecular combing technology suitable for population-studies (cohort size in concordance with the biomarker discovery market requirements)
• Genetic Morse Code allows for the target of multiple genes without need of running whole genome analysis
• GV current technology also offers a solid answer to tandem repeats and large CNVs analysis, in particular for organization and allele/phasing
• Current technology offers an attractive answer to structural variations analysis, in particular on SV complexity, highly flexible design of probes
November 2015
A pioneering approach
for genomic analysis
GENOMIC VISION’S ADVANTAGES
• BioNano Genomics & Nabsys: a whole genome approach, not allowing to analyze large cohort size
• BioNano Genomics & Nabsys: methods not user-define => not suitable for targeted genes
– Nabsys: uses universal probes (not locus specific probes)
– BNG: uses whole genome nicking enzyme (only 2 enzymes validated)
• Nanostring: a “digitally” counting methodology that limits them to analyze only CNV
– Well positioned in multigene analysis (up to 800 loci)
– The technology can not characterize SVs complexity
– Can analyze CNVs and known fusions but not detect insertion, inversion and translocations
Competitors addressing Structural Variations are not as well positioned to enable Biomarkers discovery
13November 2015
STRATEGIC ALLIANCE WITH QUEST DIAGNOSTICS
3
A pioneering approach
for genomic analysis
STRATEGIC PARTNERSHIP
Strategic alliance with Quest Diagnostics
the leader of the U.S. diagnostics market,
signed in November 2010
R&D funding
1
• Funding of internal development
• Development of lab-developed tests (LDTs) used by Quest
Commercial license
2
• Exclusive license for commercialization
in the USA for:
– FSHD test: launched in August 2013
– BRCA test (launching 4Q15)
– HNPCC test (launching 2016)
– SMA
Equity investment
3
• 14.0% stake in Genomic Vision post-IPO
(21.3% pre-IPO)
• Board member
15November 2015
A pioneering approach
for genomic analysis
RENEWAL OF STRATEGIC ALLIANCE WITH QUEST DIAGNOSTICS
16
Advantageous conditions enable Genomic Vision to increase its value-
creation potential in new indications with new diagnostics players in the US
• Partnership renewed for 3 more years until November 2018
• No opt-in right for Quest on new tests developed by Genomic Vision
• Genomic Vision has the right to develop and market new tests with other partners, including in the USA (Quest keeps exclusivity on the 4 initial tests)
• Substantial increase in royalty rate
New agreement effective since end-2014
November 2015
DIFFERENTIATED EXPANSION STRATEGY IN KEY GENETIC TESTING MARKETS
4
A pioneering approach
for genomic analysis
STRATEGIC DEVELOPMENT
Potential patient population
Proof of concept
Blockbuster
/
Game changer
BRCA
HPV & SMA
• 1st test commercialized
• Hereditary predisposition
• Large population screeningEarly-detection tests
Predisposition tests
Confirmation tests
HNPCC
FSHD
18November 2015
A pioneering approach
for genomic analysis
GENOMIC VISION’S STRONG PIPELINE
19
INDICATIONS STATUS LAUNCH MARKET POTENTIAL
MUSCULAR DYSTROPHYFSHD (Facio-Scapulo-Humeral Muscular Dystrophy)
• Launched, routine clinical use 2013 (< $50m)
BREAST CANCER(BRCA 1+2)
• Clinical validation completed
• Industrialization in process2015
(c. $500m in the USc. $2bn global)
COLON CANCERHNPCC / Lynch Syndrome
• Clinical validation on 5 genes completed
• Industrialization in process
2016 (< $100m in US)
CERVICAL CANCERHPV Integration
• Clinical validation in process 2017 (c. $300m)
SMASpinal muscular atrophy • Clinical validation launched - -
November 2015
A pioneering approach
for genomic analysis
FSHD: FIRST COMMERCIALIZED DIAGNOSTIC
• FSHD: neuromuscular genetic disease affecting adults and children
• Genomic Vision and Hôpital de La Timone developed an FSHD combing test
• 100% diagnostic sensitivity proven for FSHD combing
• Routinely used in La Timone (250+ per year)
– CE-marked in August 2013
• Commercialized by Quest Diagnostics since August 2013 at Nichols Institute
Molecular Combing test reduces the number of false negatives in FSHD
Clinically validated and already used by practitioners
Proof of concept
20November 2015
A pioneering approach
for genomic analysis
BREAST CANCER COMBING TEST: NEXT TEST TO BE LAUNCHED
Note: *Quest Diagnostics press release **Based on Myriad Genetics data, 2013
A demand exists despite little knowledgewithin the population…
… leading to attractive market opportunities
72%of Adult Women in the U.S have never heard of BRCA testing*
58%want to know for sure if they carry
high-risk gene mutations*
20%of women with family history are
undergoing the BRCA tests*
c. $500mEstimated market size in the US**
c. 140,000Tests performed in the US in
2012**
90%Myriad Genetics market share**
Global market size for BRCA is over $2bn**
21November 2015
A pioneering approach
for genomic analysis
POTENTIAL SCREENING OF BRCA LARGE REARRANGEMENTS
22
Detection of point mutations in BRCA1 and BRCA2
Patients with strong family history*(Blood sample)
POSITIVE 26% NEGATIVE 74%
100%
POSITIVE (6%) NEGATIVE (68%)
Detection of large rearrangements -
BRCA Combing test
BRCA point mutation positive-
Established genetic statue
Source: 2008, Dalla Palma et al, The relative contribution of point mutations and genomic rearrangements in BRCA1 and BRCA2 in high risk breast cancer families, Cancer Res.
*Note: in none-Ashkenazi Jewish US population
BRCA combing test targeting large rearrangements detection in all the negative samples
November 2015
A pioneering approach
for genomic analysis
HPV COMBING TEST: A “GAME CHANGER”
HPV Combing test to avoid invasive and expensive colposcopies:
• Distinguishes high-or low-risk patients
• Avoids useless invasive colposcopies
• Lowers cost to healthcare providers
23
50% of women tested positive with a conventional HPV test do not require colposcopy
ROUTINE PAP-SMEAR
Pos
Wait 1 yearRedo pap-smear
COLPOSCOPY
Clear cut resultsAmbiguous results
HPV Test HPV +
NegHPV Combing
Test
HPV -
ESTIMATED SCREENING MARKET
Women population 86.7 millions
Nb. of colposcopies per year
1.2 million
84.4 millions
1.3 million
50% 50%
November 2015
A pioneering approach
for genomic analysis
• A consortium of 8 international participants to share a €6 million grant until 2019
• Genomic Vision’s mission:
– To bring its industrial experience in the detection of structural variations involved in SMA
– To develop a test capable of identifying “2+0” carriers (carriers of both copies of the SMN 1 gene on a chromosome), which are undetectable using existing techniques
GENOMIC VISION SELECTED FOR THE HORIZON 2020 PROGRAM’S ‘BEYONDSEQ’ PROJECT WORTH €6 MILLION
A European Commission project aiming to bridge the technological gap between cytogenetic diagnostics (chromosomal aberrations) and next generation sequencing (single base-pair mutations)
24
Genomic Vision to benefit from the academic know-how in order to drive
its technology towards a new generation of molecular combing
IMPASARA Ltd.
November 2015
A pioneering approach
for genomic analysis
COMMERCIALIZATION STRATEGY IN THE US AND IN EUROPE
Two commercialization strategies for two different regions
Combined sales strategy
Direct Partnering
Current
testsFSHD, BRCA,
HNPCC
Low/medium
volume
Direct sales
to specialized
labs
Hospitals,
reference labs,
medical
research labs
Future
testsHPV, SMA
High volume
Collaboration and license to
an industrial partner
25
* The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are federal regulatory standards that apply to all clinical
laboratory testing performed on humans in the United States (with the exception of clinical trials and basic research). Source: aafp
Alliance with Quest and new potential partners
Future
testsNew indications
Collaboration and license to
new potential partners
Other partners
Tests from
the initial
agreement
FSHD, BRCA,
HNPCC, SMA
Exclusive
license to
Quest
Diagnostics
Revenues:
Royalties
CLIA*
laboratories
November 2015
A pioneering approach
for genomic analysis
KEY DEVELOPMENTS SINCE THE IPO
26
Full execution of the strategy outlined at IPO
April2014
August2014
September 2014
November 2014
December 2014
IPO
January2015
Presentation of the first
results of the HPV
detection testat the 2014
HPV Conference in
Seattle
Reinforcing the
management
• Head of Business Development
• Head of Bio-informatics /IT
• Head of HR
Commercial team set up
• David del Bourgoappointed Head of Sales & Marketing
• Setting up of a team of Sales and Marketing specialists
2014 annual revenue
from sales at €3.5 million
Solid cash position of
€22.8 million
Renewal of the strategic collaboration with Quest Diagnostics for 3 more
years
Clinical partnership with ROUEN University
Hospital for the SMA
diagnostics test
development in France
BRCA Milestone
with Quest Diagnostics
Installation of the high-throughput genome analyzer
with the new BRCA protocol at Nichols Institute
Further milestones
reached with Quest
• New version of the software for analyzing and interpreting images
• Validation of software to analyze HNPCC test results
Cash position of €18 million
February2015
November 2015
15 October 2015
22 October 2015
A pioneering approach
for genomic analysis
SUBSTANTIAL NEWSFLOW IN Q4 2015 / EARLY 2016
27
COMMERCIAL DEVELOPMENT
IN EUROPE
4
• Establishment of the molecular combing platform in new diagnostics centers
BRCA TEST(breast cancer predisposition)
3
• Launch by Quest Diagnostics in the US
HNPCC TEST(colon cancer predisposition)
• Validation and LDT development at Quest Diagnostics
2
SMA TEST(carrier screening)
• Enrolment of the first patients in the clinical study with CHU Rouen
1
November 2015
A pioneering approach
for genomic analysis
Q3 2015 FINANCIAL INFORMATION
• Change in Q3 and 9-month 2015 revenue
• Cash position of €18 million at September 30, 2015
– Includes reimbursement of 1.3 million in tax credits
Unaudited data, IFRS
28November 2015
In € thousands 9 months 3rd quarter
2015 2014 2015 2014
Revenue from Quest Diagnostics R&D 1,130 2,857 615 395
Product Sales 242 163 66 69
Total revenue from activity 1,372 3,020 681 464
Other revenue 1,050 858 305 209
Total revenue from activity 2,422 3,878 986 673
For more information visit:
www.genomicvision.com
APPENDICES
A pioneering approach
for genomic analysis
GENOMIC VISION & THE STOCK EXCHANGE
31
• IPO date: April 2nd, 2014
• Market: Euronext in Paris (compartment C)
• Share price: €10.00 (October 30th, 2015)
• High: €15.86 (March 2nd, 2015)
• Low: €9.90 (October 13th, 2015)
• Number of shares: 4,457,734
• Market Cap: €45m (October 30th, 2015)
• Average daily trading: 7,346 shares since the IPO
Shareholding structure (As of 31.10.2015)Stock market information
Stock codes
• Name: GENOMIC VISION
• Mnemonic: GV
• ISIN code: FR0011799907
• Member of CAC® Mid & Small and CAC® All-Tradable indexes
Contacts
Genomic Vision
Aaron Bensimon – CEO / Erwan Martin – CFO
Tel: +33 1 49 08 07 40
E-mail: [email protected]
Website: www.genomicvision.com
Investor Relations & Strategic Communications
Emmanuel Huynh / Dusan Oresansky
Tel: +33 1 44 71 94 93
E-mail: [email protected]
November 2015
10,1%
3,6%
13,8%72,4%
0,2% Management, founders &employees
Institut Pasteur
Quest Diagnostic
Free Float
Autocontrôle
A pioneering approach
for genomic analysis
H1 2015 FINANCIAL INFORMATION
32
In € thousands 30.06.2015 30.06.2014
Total revenue from activity 1,436 3,206
of which sales 691 2,557
R&D expenses (1,913) (2,337)
Net income (loss) (2,208) (310)
In € thousands 30.06.2015 31.12.2014
Shareholder’s equity 20,621 22,695
Financial debt 599 792
Cash and cash equivalents 18,734 22,764
Operating cash flow (2,868) (3,771)
Audited data, IFRS
November 2015
A pioneering approach
for genomic analysis
KEY 2014 FINANCIALS
33
In € thousands 31.12.2014 31.12.2013
Total revenue from activity 4,893 4,039
of which sales 3,455 2,887
R&D expenses (4,354) (3,453)
Net income (loss) (2,156) (1,069)
In € thousands 31.12.2014 31.12.2013
Shareholder’s equity 22,695 982
Financial debt 792 824
Cash and cash equivalents 22,764 3,226
Operating cash flow (3,771) 243
Audited data, IFRS
November 2015