Investor Presentation. November 2015

Transcription

1 Investor Presentation

2 DISCLAIMER This document has been prepared by Genomic Vision (the "Company") and is provided for information purposes only. This document does not purport to contain comprehensive or complete information about the Company and is qualified in its entirety by the business, financial and other information that the Company is required to publish in accordance with the rules, regulations and practices applicable to companies listed on Euronext Paris. No reliance may be placed for any purposes whatsoever 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 or amended, and thus such information may be subject to significant changes. The Company is not under any obligation to update the information or opinions contained herein 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 as to the accuracy, completeness or appropriateness of the information and opinions contained in this document. The Company, its subsidiaries, its advisors and representatives 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 or the 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 been drawn 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-looking statements relate to the Company's future prospects, developments and marketing strategy and are based on analyses of earnings forecasts and estimates of amounts not yet determinable. Forward-looking statements are subject to a variety of risks and uncertainties as they relate to future events and are dependent on circumstances that may or may not materialize in the future. Forward-looking statements cannot, under any circumstance, be construed as a guarantee of the Company's future performance 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 materially from those proposed or reflected in the forward-looking statements contained in this document. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include those discussed or identified in the Risk Factors section of our Base Document registered with the Autorité des marchés financiers on March 3, 2014 under number I (a copy of which is available on Even if the Company s financial position, results, cash-flows and developments in the sector in which the Company operates were to conform to the forward-looking statements contained in this document, such results or developments cannot be construed as a reliable indication of the Company's future results or developments. The Company does not undertake any 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 an event 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 not necessarily equal the sum of the individually rounded figures, amounts or percentages. All persons accessing this document must agree to the restrictions and limitations set out above. 2

3 KEY MANAGEMENT TEAM 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 Cytomics Pharmaceuticals Degree in Business Administration Joined Genomic Vision in

4 INVESTMENT HIGHLIGHTS 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 4

5 1 SOLID POSITION IN RAPIDLY GROWING ONCOGENETIC TESTING MARKET

6 MOLECULAR COMBING DETECTS STRUCTURAL VARIATIONS Point Mutations (SNPs) Sequencing Structural Variations Molecular Combing Chromosomic aberrations Fish (1) Scale: Single Gene (1bp-2Kbp) Scale: Large Multi Gene (3Kbp-1Mbp) Scale: Chromosome (1Gbp) BRCA2 normal gene BRCA2 mutated gene Sickle Cell Anemia Characterized by point mutation Notes: (1) Fluorescent in situ hybridization. Breast Cancer (BRCA2) Characterized by a large insertion in BRCA2 gene Trisomy 21 Down Syndrome Characterized by three copies of chromosome 21 6

7 THE IMPORTANCE OF DETECTING STRUCTURAL VARIATIONS Structural variations Most technologies cannot accurately detect structural variations, corresponding to large genomic rearrangements (LRs) in the 10Kbp 1Mbp scale range What are 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. Detecting structural variations dramatically improves clinical diagnostics & prognosis 7

8 2 MOLECULAR COMBING: PROPRIETARY AND CLINICALLY- VALIDATED TECHNOLOGY

9 UNIQUE PROPRIETARY TECHNOLOGY 1 Extracting 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 Molecular Combing 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 2 Applying morse code to the genome to enable clearcut diagnostics interpretation Genomic Morse Code A fluorescent barcode along the combed DNA molecules automatically identifies and interprets complex, often hidden, structural variations BRCA2 normal gene 10kb BRCA2 mutated gene 9

10 COMPREHENSIVE OFFERING: PLATFORM AND PRODUCTS Genomic Vision s platform Genomic Vision s consumables Molecular Combing System Hybridizers CombHeliX FSDH probes DNA Extraction kits Scanner CombHeliX FSDH Software Silanized coverslips Disposable reservoirs 10

11 FULLY INTEGRATED AND PROTECTED WORKFLOW Initial IP filed by Aaron Bensimon s team at Institut Pasteur FROM TO Combing Image Acq. Extraction Hybridization Image Anal. Robust, 130-patent portfolio supporting all steps of the Genomic Combing workflow: Extraction, Combing, Hybridization and Image Acquisition and Analysis 11

12 GENOMIC VISION S TECHNOLOGY 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 12

13 GENOMIC VISION S ADVANTAGES Competitors addressing Structural Variations are not as well positioned to enable Biomarkers discovery 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 13

14 3 STRATEGIC ALLIANCE WITH QUEST DIAGNOSTICS

15 STRATEGIC PARTNERSHIP Strategic alliance with Quest Diagnostics the leader of the U.S. diagnostics market, signed in November R&D funding 2 Commercial license 3 Equity investment Funding of internal development Development of lab-developed tests (LDTs) used by Quest Exclusive license for commercialization in the USA for: FSHD test: launched in August 2013 BRCA test (launching 4Q15) HNPCC test (launching 2016) SMA 14.0% stake in Genomic Vision post-ipo (21.3% pre-ipo) Board member 15

16 RENEWAL OF STRATEGIC ALLIANCE WITH QUEST DIAGNOSTICS New agreement effective since end-2014 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 Advantageous conditions enable Genomic Vision to increase its valuecreation potential in new indications with new diagnostics players in the US 16

17 4 DIFFERENTIATED EXPANSION STRATEGY IN KEY GENETIC TESTING MARKETS

18 STRATEGIC DEVELOPMENT Proof of concept FSHD Confirmation tests 1 st test commercialized Blockbuster / BRCA HNPCC Predisposition tests Hereditary predisposition Game changer HPV & SMA Early-detection tests Large population screening Potential patient population 18

19 GENOMIC VISION S STRONG PIPELINE INDICATIONS STATUS LAUNCH MARKET POTENTIAL MUSCULAR DYSTROPHY FSHD (Facio-Scapulo-Humeral Muscular Dystrophy) Launched, routine clinical use 2013 (< $50m) BREAST CANCER (BRCA 1+2) Clinical validation completed Industrialization in process 2015 (c. $500m in the US c. $2bn global) COLON CANCER HNPCC / Lynch Syndrome Clinical validation on 5 genes completed Industrialization in process 2016 (< $100m in US) CERVICAL CANCER HPV Integration Clinical validation in process 2017 (c. $300m) SMA Spinal muscular atrophy Clinical validation launched

20 FSHD: FIRST COMMERCIALIZED DIAGNOSTIC Molecular Combing test reduces the number of false negatives in FSHD 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) Clinically validated and already used by practitioners CE-marked in August 2013 Commercialized by Quest Diagnostics since August 2013 at Nichols Institute Proof of concept 20

21 BREAST CANCER COMBING TEST: NEXT TEST TO BE LAUNCHED A demand exists despite little knowledge within the population 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* leading to attractive market opportunities c. $500m Estimated market size in the US** c. 140,000 Tests performed in the US in 2012** 90% Myriad Genetics market share** Global market size for BRCA is over $2bn** Note: *Quest Diagnostics press release **Based on Myriad Genetics data,

22 POTENTIAL SCREENING OF BRCA LARGE REARRANGEMENTS Patients with strong family history* (Blood sample) 100% Detection of point mutations in BRCA1 and BRCA2 POSITIVE 26% NEGATIVE 74% BRCA point mutation positive - Established genetic statue Detection of large rearrangements - BRCA Combing test POSITIVE (6%) NEGATIVE (68%) BRCA combing test targeting large rearrangements detection in all the negative samples 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 22

23 HPV COMBING TEST: A GAME CHANGER 50% of women tested positive with a conventional HPV test do not require colposcopy ROUTINE PAP-SMEAR ESTIMATED SCREENING MARKET Ambiguous results Clear cut results HPV - HPV Test HPV + 50% 50% Women population 86.7 millions 84.4 millions Neg HPV Combing Test Nb. of colposcopies per year 1.2 million 1.3 million Pos Wait 1 year Redo pap-smear COLPOSCOPY 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

24 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) A consortium of 8 international participants to share a 6 million grant until 2019 IMPASARA Ltd. 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 to benefit from the academic know-how in order to drive its technology towards a new generation of molecular combing 24

25 COMMERCIALIZATION STRATEGY IN THE US AND IN EUROPE Two commercialization strategies for two different regions Alliance with Quest and new potential partners Combined sales strategy Other partners Direct Partnering Tests from the initial agreement FSHD, BRCA, HNPCC, SMA Future tests New indications Current tests FSHD, BRCA, HNPCC Low/medium volume Future tests HPV, SMA High volume Exclusive license to Quest Diagnostics Revenues: Royalties CLIA* laboratories Collaboration and license to new potential partners Direct sales to specialized labs Hospitals, reference labs, medical research labs Collaboration and license to an industrial partner * 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 25

26 KEY DEVELOPMENTS SINCE THE IPO Presentation of the first results of the HPV detection test at the 2014 HPV Conference in Seattle Reinforcing the management Head of Business Development Head of Bioinformatics /IT Head of HR Commercial team set up David del Bourgo appointed Head of Sales & Marketing Setting up of a team of Sales and Marketing specialists BRCA Milestone with Quest Diagnostics Installation of the high-throughput genome analyzer with the new BRCA protocol at Nichols Institute 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 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 IPO April 2014 August 2014 September 2014 November 2014 December 2014 January 2015 February October October 2015 Full execution of the strategy outlined at IPO 26

27 SUBSTANTIAL NEWSFLOW IN Q / EARLY SMA TEST (carrier screening) HNPCC TEST (colon cancer predisposition) BRCA TEST (breast cancer predisposition) COMMERCIAL DEVELOPMENT IN EUROPE Enrolment of the first patients in the clinical study with CHU Rouen Validation and LDT development at Quest Diagnostics Launch by Quest Diagnostics in the US Establishment of the molecular combing platform in new diagnostics centers 27

28 Q FINANCIAL INFORMATION Unaudited data, IFRS Change in Q3 and 9-month 2015 revenue In thousands 9 months 3 rd quarter Revenue from Quest Diagnostics R&D 1,130 2, Product Sales Total revenue from activity 1,372 3, Other revenue 1, Total revenue from activity 2,422 3, Cash position of 18 million at September 30, 2015 Includes reimbursement of 1.3 million in tax credits 28

29 For more information visit:

30 APPENDICES

31 GENOMIC VISION & THE STOCK EXCHANGE Stock market information Shareholding structure (As of ) IPO date: April 2 nd, 2014 Market: Euronext in Paris (compartment C) Share price: (October 30 th, 2015) High: (March 2 nd, 2015) Low: 9.90 (October 13 th, 2015) Number of shares: 4,457,734 Market Cap: 45m (October 30 th, 2015) Average daily trading: 7,346 shares since the IPO 72,4% 0,2% 10,1% 3,6% 13,8% Management, founders & employees Institut Pasteur Quest Diagnostic Free Float Autocontrôle Stock codes Contacts Name: GENOMIC VISION Mnemonic: GV ISIN code: FR Member of CAC Mid & Small and CAC All-Tradable indexes Genomic Vision Aaron Bensimon CEO / Erwan Martin CFO Tel: investors@genomicvision.com Website: Investor Relations & Strategic Communications Emmanuel Huynh / Dusan Oresansky Tel: gv@newcap.fr 31

32 H FINANCIAL INFORMATION Audited data, IFRS In thousands 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 Shareholder s equity 20,621 22,695 Financial debt Cash and cash equivalents 18,734 22,764 Operating cash flow (2,868) (3,771) 32

33 KEY 2014 FINANCIALS Audited data, IFRS In thousands 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 Shareholder s equity 22, Financial debt Cash and cash equivalents 22,764 3,226 Operating cash flow (3,771)