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The presentation and the information it contains do not constitute an offer to sell or subscribe for on the solicitation of an offer to buy or subscribefor securities in any country. This presentation should not be used as a basis for the purchase of shares in IntegraGen (the “Company”). Thedistribution of this presentation may be against the law in some countries.
The securities described in this presentation have not been and will not be registered under the U.S. Securities act of 1933 as amended (the “USSecurities Act”) and therefore cannot be offered or sold in the U.S. unless exempted from the registration requirements of the U.S. Securities Act. Anypublic securities offer in the U.S. will be carried out through a prospectus available from the Company containing detailed information about theCompany, its management Team, and its financial statements. The Company does not intend to register any, or all of this securities offered in theU.S. or to make a public securities offer in the U.S.
The Company shall not be held liable for any losses or damages resulting from the use of this document or the information it contains. The Companydoes not make any express or implied guarantee that the information contained in this document is free from errors or omissions. None of theinformation contained in this document should be considered as a commitment or a guarantee provided by the Company.
This documents contents forward-looking statements and comments about the Company’s strategy and objectives. The Company may not be able toreach these objectives and the Company is under no obligation to update the forward-looking statements. Actual results may differ materially fromthose expressed or implied in the forward-looking statements. The forward looking statements involve inherent uncertainties and are subject tonumerous risk factors such as those described in the Company’s registration document. Past performance is not an indication of future performanceand persons in need of advice should contact an independent financial advisor
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Blood Tissue
Nucleic acid
4
Agreement with APHP
Initial quotation of ALINT in2010, Public offering onAlternext in 2014
2016 Revenues : €6 m
HQ in Evry’s Genopole, officesin Paris & Cambridge (Mass, US)
38 employees
Bernard Courtieu, DVM, MDA – CEO Previously Cap Gemini Consulting, VP Life Sciences – France, and Ariba, Head of French Operations
Laurence Riot-Lamotte
CFO
Emmanuel Martin, R.Ph.VP, IntegraGen Genomics
Francis Rousseau, PhD Head of Genomics Operations
Bérengère GeninHead of Bio-IT
Institut Pasteur sequencing
platform
1st clinical sequencing
platform in EU
Launch of ARISk® Test
in USA
First oncology biomarker
patent
NGS
sequencing
Genomic services platform
Company founded in Evry, France
Larry Yost, RPhGM, IntegraGen Inc.
5
IntegraGen Confidential
Exec Committee Members
CEO
Office Manager
US headVP US Operations
CFO
3p
BU Genomics
BU head
VP Genomic Services
GECO
IT- Soft devpt
BD
2p
DEVELOPMENT
3p
8p
Bio-Info
BU Diagnostics
BU Head
VP Diagnostics
PROD.
1p
R & D
2p
BD AND M&S
1p
EVRY- Seq
EVRY- Gen
PASTEUR
VILLEJUIF
LABS
11p
Bioinfo & IT Director
COO - Q
GenomicsOperations,
Quality, Investment
maintenancereporting
6
Sequencing technologies, Largest French private provider,
Exome sequencing for clinical research ("clinical grade"),
Ct DNA sequencing / exome & mutational load from blood,
IT interfaces / bioIT team / Exome interpretation software,
Industrialization already demonstrated at Gustave Roussy & Institut Pasteur,
Specific, protected companion diagnostic biomarker (miRpredix-31-3p), CE marked Dx kit.
Backed by an internal Quality Management System
77
What makes IntegraGen Genomics unique ?
www.integragen-genomics.com
8
R&D centers (Academic, Pharma, AgVet, Biotech)
Cancerology centers, hospitals
Institut Pasteur
R&D centers
Data quality, speed, data support, analysis pipeline
Industrialization of process, speed of response, interface for biologist
(data viewer & dashboard)
Speed, specific implementation steps, dedicated LIMS
Digging into data sets, providing bio-IT expertise, specific pipelines
Genomics services –
High throughput
Sequencing
for clinical research
Sequencing in microbiology
Genomic consulting
The business unit dedicated to generating molecular information
9
Exome / Target seq Genome SNP Genotyping Pharmacogenetics Genome profiling
RNA-Seq Small RNA-Seq HT RT-Q PCR Digital gene expression
(Nanostring)
Meth arrays Illumina Methyl-Seq RRBS ChIP-SEQ
Study Design
New applications d
protocols set-up
Developments in
bioinformatics et
biostatistics
Online applications for
results navigation
(ERIS, OSCAR)
LIMS Development
Production platformset-up
Main LaboratoryGénopôle d’Evry
High Throughput Platform
Large Study Management & Production
Developments of new protocols and analysis
pipelinesSince March 2015
Plateforme IG
Institut Pasteur
High ThroughputRoutine Sequencingfor microbialstrains (CNR)
Since Mai 2014
Plateforme IG
Gustave Roussy
Exomes et RNASeqsequencing for
patients in clinicaltrials
10
Direct access to analyzed and pre-filtered results through graphical interface and intuitive filters
Quick check of known genes and hotspots
Open to external databases
Easy report generation
10
11
* CAGR : Compounded Average Growth Rate
2016 highlights
• Continued development of clinical & operated platforms +30% in 2016.
• Significant price pressure & erosion on R&D segment in 2015 impacting growth in value – stabilized in 2016.
• New partnership with APHP, with first revenues expected in 2017
• Extremely satisfied customers : “Thank you for this remarkable piece of work; we’re very pleased – just have to write the paper now and wished we had known you before” .
1.2
2.32.8
3.2
4.6 4.7 5.4 5.6
4.2 4.2 -
0,4
1,41.8
1
2
3
4
5
6
7
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Genomics Revenues R&D segment
Clinical
R&D
in million €
12
The evolution of cost per base has not led to a reduction of total cost of genomic research, but to a similar increase in data production : the “Geno-Tsunami”
From 2005 to 2010, IntegraGen was providing mostly raw data
In 2010 IntegraGen launched its first genomic data viewer ERIS
ERIS allows sequencing services customers to view the genomic data and filter data from all types of queries
In 2013, IntegraGen launched OSCAR, the Online Screening tool for Cancer, with a clinically relevant interface, developed in conjunction with Gustave Roussy biologists & oncologists
In 2014 IntegraGen, Sogeti HT, Gustave Roussy & INSERM announced the launch of the ICE project – objective is to transform whole exome data into optimization of cancer treatment
13
2. Nucleic acidsreception
3. Librairies preparation
5. Bio-informatic analysis6. Variants selection
1. Sample prep
7. Variants validation & report editing
4. NGS NextSeq5002 patients/day
Tumor Board
1414
Beta test version in Q1 2017
“the development of targeted therapies and immunotherapies in thetreatment of solid tumors has significantly changed the management ofpatients with cancer”
ICE is Project to develop an advanced software program which supports interpretation of
exome and transcriptome data obtained from tumor and healthy tissue from patients.
optimize the diagnosis of cancer and provide data for identifying :
‒ genomic alterations which potentially predict response to drug therapies
‒ context information from public and premium content sources and potentially relevantclinical trials
‒ optimal treatment approaches
15
… stabilized …
• Exome, genome and panels now routinely used for close to a decade
… affordable …
• When compared to total cost of care, with pricesranging from '00s to '000s of euro per test
… clinically usefull…
• To orient patients towards targeted therapies, immunotherapies, …
… and cost effective
• Ct DNA – Liquid biopsies becoming new gold standard in tissue analysis.
Biologists
• Information required to be both available but also managedvia intelligible interface.
Cancer specialists / oncologists
• Liquid biopsies becoming new gold standard in tissue analysis .
• Usefull (actionable) information when deciding whichtherapy to use, which clintrials to orient patient to,
Patients
• Making sure treatment choices are made using the latestavailable options optimizing survival .
Payors
• Reducing unefficent therapies.
Sequencing technology is now… What it means for
Regulatory landscape is now the critical driver of clinical adoption in Europe
16
Leading private genomic lab in France
Key contributor to the Genomic 2025 French National Plan
Partner of the leading French institutions (G. Roussy, Pasteur, AP-HP, others tba)
Able to deliver timely high-qualiy analysis
Able to industrialize & implement"turnkey"solutions (GR live in 8 weeks, IP in 12)
Access to clinical use of results Onco panels (or exome)
Interpretation software
Access to other geographies to replicateGR/IP pilot model South Europe
Germany & East Europe
UK
Access to other geographies to replicateGR/IP pilot model South Europe
Germany & East Euro
1717
Diagnostics
www.integragen-genomics.com
1818
A few biomarkers in mCRC in the portfolio
miR-31-3p potential development in NSCLC
Partnershp with Big pharma to develop TKIspecific marker in NSCLC
Strategic decision NOT TO develop newmarkers on own funds, but to co-developmarkers with drug manufacturer
Single biomarker test RT-qPCR
Patented, co-owned by IntegraGen withexclusive licensing rights
Improve patient selection for anti-EGFRtherapies
‒ Increased ability to identify responderscompared to KRAS testing alone
Potential for rapid adoption
‒ Established screening program for KRAStesting
+ possible predictive utility in Lung Cancer
19
Metastatic Colorectal Cancer (mCRC) patients can be treated by:
Traditional surgery & Chemotherapy (FolFox, Folfiri, Folfirinox)
Targeted therapies
Anti VGF (Avastin® Roche)
Anti-EGFR (Erbitux® Merck-Lilly; Vectibix® Amgen)
Choice of targeted therapy varies across geographies, but consensus considers
Avastin is considered first treatment of choise in US &² Japan as it is not related to any biomarker prior to treatment
When only eligible patients (wild KRAS, c. 50% of population) can benefit from anti-EGFR patients will vary from low to high, with high variability of reponse and some side effects
Even though Half of the patients would be significantly better off if started with anti EGFR
Targeted population
US : 140,000 new cases of mCRC/year
Of which 50% are KRAs wild type (eligible for anti-EGFR treatment)
i.e. 70k to 140k patients in the target population
Western Europe : 170,000 new cases of mCRC (id)
Rest of world : 500,000 new cases
Business potential
US : 250 m$
West Europe : 250 m$
20
2011/2012 analysis of academic retrospective collections
2013-2015 analysis of prospectively gathered samples from randomized phase III trials
Initial discovery Replication studies
33 pts 99 pts
Platform presentation @ ESMO, 2 posters (2013) and published in Clinical Cancer Research
(2014)
“miR-31-3p seems to be a new mCRC biomarker whose expression allows for the identification of patients likely to respond to anti EGFR therapy”
NEW EPOC PICCOLO FIRE 3
272/ 158 460 / 188 592 / 370
2 ASCO posters & platform presentation (2013 / 2014)
Predictive biomarker of cetuximab effect
2 posters – ESMO (2014) and ASCO (2105)
Validation of role of biomarker
Chemo + Cetuximab
vs.
Chemo alone (FOLFOX)
Chemo + Pani.
vs.
Chemo alone (Irinotecan)
Chemo + Cetuximab
vs.
Chemo + Bevacizumab
(FOLFIRI)
Tota
l of
84
8 p
atie
nts
in 9
ind
epen
den
t co
ho
rts
* total # of patients (pts) in trial / # of patients RAS wild type analyzed
Abstract presented at plenary session ASCO
2016
Validation of threshold, predictive value and
clinical utility (in choice of 1st line therapy)
21
KRAs / all RAS wild : 50%
KRAS (40%) / all RAS (10%) mutated : 50%
BevacizumabCetuximab
Median OS
27.4 m [23.7 ; 32.4]
39.4 m [31.0 ; 52.0]
Low: miR-31-3p < cut-off (n = 245)
Median OS
20.1 m [14.5 ; 30.8]
20.3 m [14.7 ; 27.1]
BevacizumabCetuximab
High: miR-31-3p ≥ cut-off (n = 125)
12 Months difference at median OS for low expressors or miR-31-3p
Analysis of the FIRE-3 samples
Which targetted therapy to add to traditional Chimio
(Folfox/folfiri)
Avastin(only available option)
EitherAvastin / Erbitux
Erbitux(12 Months OS
advantage)
all RAS/KRAS mutated :
50%
miR-31-3p Low 34%
miR-31-3p high : 16%
all RAS/KRAS wild type
50%
What is the molecular status of a specific patient?
Metastatic colorectal cancer (mCRC)84,000 annually (US) - 170,000 (EU)
22
USA Europe
Licensing deal with CLIA lab
Clinical utility study (TBD) run at licensing partner’s lab
Reimbursement via Medicare and private payors
Incorporation into NCCN/ASCO guidelines
Design developmental deal with subcontractor/partner
Reference lab / distributors
RIHN guidelines – filed by HEGP on Sept 15
Certified CLIA lab On-going negociations withUS CLIA lab – term sheet
CE marked kit manufacturing
On-going negociations withreference labs
23
June-16 Sept-16 Oct-16
Process validation - Production of 3 batches
- Stability study- CE marking final dossier
Feb-17 Jun-17
17/01/17
✔
Done
On-going
Implementation- Engineer recruitment✔- Equipment acquisition✔- Installation and
qualification of the equipments✔
- Technical validations
Riskanalysis✔
Product Definition- Technology✔- Standard ✔-
2424
25
+ 8% in revenues versus FY 2015 Growth in clinical genomics (Gustave Roussy and Pasteur) +30% versus 2015
GECO (Genomic Consulting) launched in Q2 2015
Revenues on R&D segment stable after price erosion in 2015
2016 results to be communicated on April 7, 2017
26
Stock price : 3,35 €
# stock units : 5 070 322
# of options : 772 000
Market cap : 17 M€
Eligible PEA-PMEAverage volume - 1 month 31 681
Average volume - 3 months 21 716
Average volume - 6 months 23 963
BIOAM 12.9%
Other historic 8,2%
Other
IDINVEST 12,4%
27
IntegraGen Confidential
In millions of euros 2015 2014 Var. %
Revenues 5 584 6 036 (7%)
Operating subsidies and other
revenues269 138 ns
Total Revenues 5 853 6 174 (5%)
Operating costs (8 170) (7 875) (4%)
Operating profit (2 317) (1 701) (36%)
Financial Profit/Loss (91) 284 n/a
Exceptional Profit/Loss 549 (91) n/a
Taxes (CIR) 326 464 (30%)
Net result (1 533) (1 044) (47%)
2015 financial highlights
Very low net cash consumption, € 0,2 m
Strong cash position as of Dec 31st : € 5.0 million
Slight decrease in revenues : € 0.3 m (-5%)
Strong growth in clinical genomic services
Pricing pressure on the R & D segment
Cost control continuing to progress while financing important developments
Establishment of a financing line with SociétéGénérale: 100,000 warrants exercised in July (2% of the capital)
28
KEY INDICATORS - in thousand €S1 2016
(6 mois)
S1 2015 (6 mois)
Var. %
Sales 2 880 2 624 + 10%
Total revenues 3 034 2 678 + 13%
Operational results - 1 152 - 1 343 + 14%
Net result - 1 028 - 872 - 18%
2929
30
Grow of partnerships in clinical genomics • Access new clinical genomic platforms as the sole or partner operator
Enlarge digital genomics offering
• Continue development of clinical sequencing offers such as circulating tumor exome, low DNA quantity
• Develop & market bio-informatics software• Grow GeCo expertise and IT support
Launch miRpredX diagnostic kit in Europe, achieve industrial partnerships • Licensing partners in North America and in Europe
Select R&D partnerships• Access to clinical trials relevant for miR-31-3p biomarker in Colorectal and Lund cancer
• Companion Dx agreement
31