- All planned 2015 development
milestones achieved
- Good management of operating
costs
- Solid cash position of €15.6
million
Regulatory News:
Genomic Vision (Paris:GV) (FR0011799907 – GV), a
molecular diagnostics company specializing in the development of
diagnostic tests for genetic diseases and cancers based on
molecular combing technology, today announces its full-year
results1 to December 31, 2015 according to IFRS, as approved by the
Management Board and examined by the Supervisory Board on March 21,
2016.
2015 annual results
In thousands of euros - IFRS
2015
2014 Revenue from R&D Quest Diagnostics
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 Net operating
expenses -8,708 -7,107 Operating profit
/ loss -4,391 -2,214
Net profit /
loss -4,338 -2,156
In 2015, Genomic Vision recorded revenue from sales of €2,360
thousand. With €2,069 thousand of this figure consisting of revenue
from its R&D collaboration with Quest Diagnostics, it recorded
an expected decrease associated with the gradual end of the
milestone payment planned in the initial agreement with Quest
Diagnostics. These payments totaled €3,218 thousand in 2014.
Revenue from product sales increased by +22.8% to €291 thousand,
and reflect a positive momentum for Genomic Vision’s three sources
of sales revenue:
- direct sales of the CombHelix FSHD test
at the Timone hospital in Marseille,
- royalties paid by Quest Diagnostics,
which distributes this test in the United States, and
- direct sales of consumables and
instruments to laboratories that use molecular combing technology
for research purposes (Life Sciences Research Tools).
Revenue from activity totaled €4,317 thousand in 2015, versus
€4,893 thousand in 2014 after other revenue of €1,957 thousand
corresponding to tax credits (research tax credit and innovation
tax credit totaling €1,303 thousand) and R&D subsidies (€654
thousand) are taken into account. The latter notably includes
repayable advances from Bpifrance (ex-OSEO) related to two R&D
projects accounted as revenue in the P&L statement following
the end of the programs.
Operating expenses totaled €8,708 thousand over the year to
December 31, 2015, up 22.5% compared with the figure at end-2014,
reflecting good control of the Company’s spending over the
period:
- R&D costs, the largest category of
expenditure, remained stable compared with the previous year,
- General costs increased by +36.4%, due
to non-recurring expenses associated with strategic consulting
services and the extension of the head-office premises,
- Sales & Marketing costs almost
tripled to €1,222 thousand. This increase was due to the setting up
of a technical sales team whose workforce doubled in 2015, in
accordance with Genomic Vision’s intention of developing its own
sales and marketing capacities.
At December 31, 2015, Genomic Vision had 54 staff, compared with
46 at December 31, 2014.
Over the year to December 31, 2015, the Company recorded an
operating loss of -€4,391 thousand, compared with
-€2,214 thousand at December 31, 2014.
Taking into account a financial profit (+€54 thousand), the 2015
net loss was thus -€4,338 thousand, compared with -€2,156 thousand
at December 31, 2014.
Solid cash position
As indicated when annual revenue was published in January, cash
and cash equivalents totaled €15.6 million at December 31, 2015,
versus €22.8 million at December 31, 2014, illustrating the
Company’s effective management of its spending within a context of
high investments with the acquisition of high-throughput scanners
to be installed among the Company’s clients and partners.
At December 31, 2015, the Company’s financial structure remained
solid, with shareholders’ equity of €18.4 million and almost no
remaining financial debt (€22 thousand of leasing), since repayable
advances from Bpifrance have been accounted as revenue in the
P&L statement.
2015 highlights: all planned objectives successfully
met
Favorable renewal of the strategic partnership with Quest
Diagnostics
Genomic Vision renewed its strategic partnership with Quest
Diagnostics, the American group that is the global leader in
laboratory diagnostic services, through to November 2018. Quest
Diagnostics remains Genomic Vision’s exclusive partner for the
tests developed together, but the Company can develop and market
new tests with other partners in the United States and worldwide,
and the royalty rate paid to Genomic Vision has been revised
up.
Optimization of the automatic molecular combing
platform
Genomic Vision has improved the automatic platform installed at
Quest Diagnostics with:
- a generic version of the
high-throughput scanner’s image analysis and interpretation
software applicable to all of the Company’s tests;
- an automatic DNA extractor optimized
for molecular combing technology.
Quest Diagnostics thus has all the necessary tools it needs to
develop the LDT (Laboratory Developed Test) version of diagnostic
tests using molecular combing.
Significant progress in the development of the SMA (Spinal
Muscular Atrophy) test
Genomic Vision has launched a clinical trial, in partnership
with Rouen University Hospital, on 360 patients, the enrollment of
which began at the end of the year.
Genomic Vision has also been selected for the Horizon 2020
program’s BeyondSeq project, which is financed by the European
Commission. This program will contribute to the development of an
SMA test capable of identifying healthy carriers, who are
undetectable using existing techniques.
Vast clinical trial with Reims University Hospital to develop
a test for the early detection of cervical cancer
This study, which comprises two phases, aims to validate the
integration of the high-risk human papillomavirus (HPV-HR) as an
indicator of the severity of cervical lesions and the risk of
developing cervical cancer. The first 3-year phase involves the
analysis of 3,500 patients in 11 French hospitals. The second phase
will monitor, for a further 3 years, patients who have tested
positive for HPV infection. This study is actually the largest ever
undertaken using the molecular combing technique.
Strategic partnership with the Imagine Institute
The partnership with Europe’s largest genetic research and care
cluster has led to the installation of a comprehensive molecular
combing platform at the Necker-Enfants Malades hospital. The
purpose of this partnership is to identify pathologies caused by
complex structural DNA variations that are difficult to identify
with existing methods, and to contribute to the development of new
high-value-added genetic tests that will enrich Genomic Vision’s
product portfolio.
Strengthening of the Company’s governance and senior
management
Genomic Vision strengthened its senior management team via the
recruitment of 3 experienced managers: Mr. Camille Chypre as
Vice-President R&D, Mr. Stéphane Altaba as Vice-President
Corporate Development and Mrs. Anne Jacquet as Medical
Director.
Moreover, the Shareholders’ Meeting of June 30, 2015 approved
the appointment of two new members of the Supervisory Board, Mrs.
Elisabeth Ourliac, Vice President and Director of Corporate
Strategy at the Airbus Group, and Mrs. Tamar Saraga, International
Executive Advisor in Mergers & Acquisitions and Strategy.
Recent events and outlook
Positioning study with Quest Diagnostics for a test of
predisposition to breast and ovarian cancer
This clinical trial, which plans to analyze between 500 and
1,000 de-identified DNA specimens, reflects Quest Diagnostics and
Genomic Vision’s shared intention of maximizing the success of the
launch of the BRCA test by Quest on the American market. This study
should be completed by this coming summer.
Molecular combing singled out in a study published by Nature
review’s Scientific Reports
Published by researchers from the Rockefeller Institute,
Princeton University, Nobel Prize winner Sir Paul M. Nurse from the
Francis Crick Institute and Aaron Bensimon, Co-founder and Chairman
of Genomic Vision, this study highlights molecular combing’s
considerable potential as a research and discovery tool, notably
thanks to its ability to analyze larger DNA fragments, or even
entire chromosomes, of up to 12 Mb in human cells.
Erwan Martin, CFO of Genomic Vision, comments: “Our
financial results highlight two major facts regarding our
achievements over the past year: firstly, every objective planned
in the collaboration with Quest Diagnostics was met, resulting in
revenue from activity in line with our expectations; secondly, the
technological development of the combing platform, which is now
automated, and the structuring of our organization, with the
strengthening of the Business Development division, were achieved
while limiting the increase in our operating spending. In 2016, we
are planning to continue the development of our tests and clinical
studies, which will enable us to extend the use of molecular
combing technology across the diagnostics and research
markets.”
Next financial publication
- Revenue for the 1st quarter of 2016, on
Tuesday May 10, 2016* (before market)
* indicative date that may be amended
ABOUT GENOMIC VISION
Founded in 2004, Genomic Vision is a molecular diagnostics
company that specializes in the development of diagnostic tests for
genetic diseases and cancers based on molecular combing. Using this
innovative technology that allows the direct visualization of
individual DNA molecules, Genomic Vision detects quantitative and
qualitative variations in the genome that are at the origin of
numerous serious pathologies. The Company is developing a solid
portfolio of tests that initially target breast and colon cancers.
Since 2013, the Company has marketed the CombHelix FSHD test for
identifying facioscapulohumeral dystrophy (FSHD), a myopathy that
is difficult to detect. It is marketed in the United States through
a strategic alliance with Quest Diagnostics, the American leader in
diagnostic laboratory tests, and in France directly by the Company.
Genomic Vision has been listed on Compartment C of Euronext Paris
since April 2014.
ABOUT MOLECULAR COMBING
DNA molecular combing technology significantly improves the
structural and functional analysis of DNA molecules. DNA fibers are
stretched over glass slides, as if "combed", and uniformly aligned
over the entire surface. It is then possible to identify genetic
anomalies by locating specific genes or sequences in the patient's
genome using genetic markers, a technique developed by Genomic
Vision and patented under the name Genomic Morse Code. This
exploration of the entire genome at high resolution via a simple
analysis enables the direct visualization of genetic anomalies that
are undetectable by other technologies.
For further information, please go to: www.genomicvision.com
Member of CAC® Mid & Small, CAC® All-Tradable
and EnterNext© PEA-PME 150 indexes
1 Audit procedures relative to these accounts have been carried
out. The auditor’s report will be issued after completion of the
procedures required for the purpose of filing the “document de
reference” (reference document).
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160321006407/en/
Genomic VisionAaron Bensimon, +33 1 49 08 07
50Co-founder, Chairman &
CEOinvestisseurs@genomicvision.comorKalimaRelations
PresseEstelle Reine-Adélaïde, +33 6 17 72 74 73Florence Calba, +33
1 44 90 82 54era@kalima-rp.frorLHAInvestor Relations USAnne
Marie Fields,
212-838-3777SVPafields@lhai.comorNewCapInvestor Relations /
Strategic CommunicationsDušan Orešanský / Emmanuel Huynh, +33 1 44
71 94 92gv@newcap.eu
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