- Sales of products and services up
+55%
- Increase in operating expenses in
line with the scaling up of R&D and Marketing
activities
- Cash position of €11.0
million
- Appointment of two new members to
the Supervisory Board
Regulatory News:
Genomic Vision (Paris:GV) (FR0011799907 – GV), DNA
molecular combing specialist that develops tests for the
diagnostics market and tools for the life sciences research market,
today announces its first-half results1 to June 30, 2016, as
approved by the Management Board and examined by the Supervisory
Board on July 25, 2016.
2016 first-half results
In thousands of euros - IFRS
H1 2016 H1
2015 Revenue from Quest Diagnostics R&D 154
515 Product sales 273 176
Total revenue from
sales 426 691 Other revenue
847 745
Total revenue from activity
1,273 1,436 Net operating expenses
5,293 3,677 Operating profit / loss -4,020
-2,240
Net profit / loss -3,984
-2,208
Genomic Vision recorded revenue from sales of €426 thousand in
the first half of 2016, versus €691 thousand in the first half of
2015. This decrease, which was expected, was due to the decrease in
revenue from the Company’s R&D collaboration with Quest
Diagnostics (milestone payments) following the completion of joint
development programs in 2015.
Product sales, which for the first time accounted for the
majority of the Company’s revenue from sales (64%), increased by
+55% to €273 thousand, a similar level to the sales recorded over
the entire 2015 financial year (€291 thousand). This performance
confirms the positive momentum on both of the markets addressed by
Genomic Vision:
- In-vitro Diagnostics (IVD): +40%
increase in revenue from direct sales of the CombHelix FSHD test at
the Timone hospital in Marseilles and royalties paid by Quest
Diagnostics, which distributes this test in the United States.
- Life Science Research Tools (LSRT):
+59% increase in revenue thanks to sales of consumables and
instruments for studying DNA replication and of the innovative
solutions offer regarding the quality control and optimization of
genetic editing.
Once other revenue of €847 thousand corresponding to tax credits
(research tax credit, innovation tax credit) and R&D subsidies
is taken into account, total revenue from activity totaled €1,273
thousand in the first half of 2016 compared with €1,436 thousand in
the first half of 2015.
Over the first half of 2016, operating expenses increased by
+44% to €5,293 thousand, in line with Genomic Vision’s development,
and broke down as follows:
- R&D costs, the largest category of
expenditure, grew by +50% to €2,876 thousand, driven by clinical
trials initiated at the end of 2015 (SMA study undertaken with
Rouen University Hospital and HPV study with Reims University
Hospital) and in early 2016 (BRCA study with Quest Diagnostics) and
by the strengthening of the Management team in the second half of
2015;
- Sales & Marketing costs increased
by +115%, following the strengthening of the sales team and the
costs associated with the development and implementation of the
partnership strategy on the IVD and LSRT markets;
- General costs saw a moderate increase
of +9% to €1,339 thousand.
Genomic Vision’s workforce increased from 49 staff at June 30,
2015 to 62 at June 30, 2016.
The operating loss at June 30, 2016 was -€4,020 thousand,
versus -€2,240 thousand at June 30, 2015.
Taking into account a financial profit of €37 thousand, the net
loss at June 30, 2016 was -€3,984 thousand, compared with -€2,208
thousand at June 30, 2015.
Cash position and financial structure
At June 30, 2016, Genomic Vision had cash and cash equivalents
of €11.0 million, compared with €15.6 million at December 31, 2015.
Cash burn over the half, slightly up on the same period of 2015,
was in line with the increase in operating expenses and the
acquisition of high-throughput scanners to be installed among the
Company’s clients and partners.
During the second half of 2016, Genomic Vision should receive
the reimbursement of €1.3 million in research and innovation tax
credit that were booked and recorded at December 31, 2015.
At June 30, 2016, the Company had shareholders’ equity of €14.4
million and very low financial debt of €5 thousand (exclusively
leasing), versus €18.4 million and €22 thousand respectively at
December 31, 2015.
Erwan Martin, CFO of Genomic Vision, comments: “These
results for the first half of 2016 are in line with our development
strategy that was intensified over the period via a new growth
area: the life sciences research market. We are delighted with our
strong sales growth on both the historical diagnostics segment,
with the CombHelix FSHD test, and this new research market, where
we are seeing substantial demand for our technology. This
illustrates its versatility, with applications in fields as diverse
as clinical diagnostics, DNA replication and the control and
optimization of genetic editing. Thanks to our healthy and solid
financial structure, we have the necessary resources to continue
our development in these two high-potential areas.”
H1 2016 highlights
Launch of a positioning study for the BRCA testAt the
start of 2016, Genomic Vision and its American partner Quest
Diagnostics launched a study to strengthen molecular combing’s
clinical value in identifying novel cancer-causing BRCA gene
variants. The two partners’ strategic objective is to maximize the
success of Quest’s launch of this test on the American market.
Publications and scientific congresses
- Molecular combing was the subject of an
article published in January 2016 in Nature’s Scientific Reports by
a number of distinguished researchers including Nobel Prize
laureate Sir Paul M. Nurse. The article reported the results of a
study highlighting molecular combing’s ability to analyze larger
DNA fragments, or even entire chromosomes, a significant
breakthrough for studying the human genome.
- Prof. Christine Clavel, molecular
biologist at Reims University Hospital, presented the IDAHO
clinical trial, launched in late 2015 in France, during an oral
session at the Eurogin Congress held in Salzburg (Austria) from
June 15 to 18, 2016. The study aims to validate the integration of
the oncogenic, i.e. high-risk, human papillomavirus (HPV-HR) as an
indicator of the severity of cervical lesions and the risk of
developing cervical cancer.
Strategic development on the Life Sciences Research Tools
(LSRT) marketAt the end of March 2016, Genomic Vision
introduced a supplementary area of development targeting the LSRT
market. Via this initiative, Genomic Vision aims to maximize
molecular combing’s potential on a major and accessible market
estimated at 700 million dollars2, via tools dedicated to studying
DNA replication and gene editing quality control and
optimization.
Launch of the EasyScan serviceIn keeping with its
development on the LSRT market, Genomic Vision recently launched
this new service to enable researchers studying DNA replication
through molecular combing to remotely and more quickly access the
results of their work.
Recent events and outlook
Acceleration of the HPV clinical program in the field of
cervical cancerSimultaneously with the IDAHO trial currently
being undertaken in France, the Company has launched an additional
study on the HPV test in 2 reputed hospitals in the Czech Republic.
The study, which aims to validate Genomic Vision’s test as a
biomarker for the diagnostics of cervical cancer, foresees the
inclusion of 993 female patients, and the initial results are
expected in early 2017.
Appointment of two new members to the Supervisory
BoardWithin the framework of its gender parity policy
concerning the Supervisory Board, Genomic Vision will ask the next
Shareholders’ Meeting to approve the appointment of two new
independent Board members:
- Mrs. Beth Jacobs, who is
American, is Managing Director / Partner at Excellentia Global
Partners, a global life sciences investment bank. With an MBA from
American University in Washington DC, Mrs. Jacobs has 25 years of
experience in investment banking and has held various executive
positions in prestigious companies such as ING Barings and Morgan
Stanley.
- Mrs. Isabelle Racamier, who is
French, is Managing Director of Arlys Consulting GmbH, an Austrian
consulting firm that advises life sciences companies on their
strategies. With a Masters in Management from the ESCP Europe
business school in Paris, Mrs. Racamier has 30 years of experience
in product marketing and strategic planning consulting for major
pharmaceutical companies (Novartis, Boehringer Ingelheim,
Sanofi-Aventis).
These appointments follow the departure of two members of the
Supervisory Board:
- Mr. Bernard Malfroy-Camine, a
continuous member of Genomic Vision’s Supervisory Board since
November 2005,
- Mr. Jean-Yves Nothias, Head of
Life Sciences at SGAM / Amundi, the leading private equity fund in
Genomic Vision’s shareholding structure. Mr. Nothias was a member
of the Board as SGAM / Amundi’s representative until 2011, than
personally from 2012.
Genomic Vision’s Supervisory Board will thus have 8 members,
half of them women.
Aaron Bensimon, Genomic Vision’s co-founder and Chairman,
comments: “Firstly, on behalf of the entire Genomic Vision
team, I would like to wholeheartedly thank Bernard Malfroy-Camine
and Jean-Yves Nothias for their invaluable contribution to Genomic
Vision’s development, with their sound advice helping the Company
to transform itself from a start-up into a listed company that is
recognized in its field of activity. I am also honored and pleased
to welcome to our Supervisory Board Beth Jacobs and Isabelle
Racamier, two highly-experienced professionals. Their complementary
expertise in finance and marketing, acquired in major well-known
groups, will be essential to Genomic Vision’s strategic development
initiated by us during the last semester. We intend to successfully
complete our clinical studies in the field of diagnostics so that
we can offer doctors and their patients very high-potential tests
such as BRCA or, in the longer term, HPV, but also provide new
opportunities in the field of research. We strongly believe that,
thanks to our powerful technology, our teams’ expertise and the
involvement of our advisors, we will successfully meet these
objectives.”
Next financial publication
- Revenue for the third quarter of 2016,
on Friday October 28, 2016 * (before trading)
* indicative date, which may be
subject to change
ABOUT GENOMIC VISIONFounded in 2004, Genomic Vision is a
DNA molecular combing specialist that develops tests for the
diagnostics market and tools for the life sciences research market.
Using its 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 COMBINGDNA 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 Half-year accounts have been the subject of a limited review
by the Company’s auditors.
2 United States & 3 EU countries (FR, UK, DE); Source:
Company
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160726006101/en/
Genomic VisionAaron Bensimon, Tel.: +33 1 49 08 07
50Co-founder, Chairman &
CEOinvestisseurs@genomicvision.comorKalimaRelations
PresseEstelle Reine-AdélaïdeFlorence CalbaTel.: +33 6 17 72 74 73 /
+33 1 44 90 82 54era@kalima-rp.frorLHAInvestor Relations
USAnne Marie Fields, SVPTel.:
212-838-3777afields@lhai.comorNewCapInvestor Relations /
Strategic CommunicationsDušan Orešanský / Emmanuel HuynhTel.: +33 1
44 71 94 92gv@newcap.eu
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