ESPERITE N.V. Trading Update. Q1 confirms strategy and forecasted growth with Genoma
(Thomson Reuters ONE) -
The company is now building the future. CryoSave is on track and Genoma shows
its ability to support the current published forecasts and ambitious next
developments.
Zutphen, The Netherlands - 19 May 2015
ESPERITE N.V. (Euronext: ESP, 'ESPERITE', or 'the Group') announces its trading
update for the quarter ended 31 March 2015. ESPERITE has accomplished
significant milestones set forth for Q1. Economic circumstances have improved
over the past months and ESPERITE is confident that the incremental revenues
forecasted for its multiproduct strategy will outgrow the market. ESPERITE's
strategic development is fully on track.
GENOMA: Already in line with its forecasts. Confirmed by growing numbers of
sales and numerous distribution and partnership agreements.
The most recent division of the group, active in the fields of proteomics and
genomics predictive medicine is positioned in the genetic test market with a
sustainable competitive advantage to be dominant and capitalize on the current
opportunities the European market presents in which the group has proven with
its other activities its abilities to grow.
The Company has reached its milestones in volume of sales, presales and schedule
of development and launch of new products.
Creation of a pole of excellence and R&D.
Genoma , creating a unique pipeline of new-generation genetic tests, eases its
clients the key genetic information to personalize their health-related
decisions, fostering a new culture of consumer empowerment towards a proactive
approach to health. GENOMA (www.genoma.com) is at the forefront of technological
and scientific innovation.
Genoma strengthens its strategy and masters the technology.
The commercial activity is in line with the forecasts and the expectations for
the future are promising.
The Company is now preparing to enter France, Belgium, Austria and Germany
adding an additional 160 million to its target population. Further countries in
the SEE-MENA region are currently launching the new products. Further
significant growth for GENOMA is expected due to an increasing number of
developments during the first months of 2015.
Acquisition InKaryo Inc. US start-up specialized in bioinformatics for genetic
diagnostics and molecular cytogenetic tests.
ESPERITE acquired InKaryo Inc., the US-based company from Silicon Valley
specialized in cytogenetic analysis through next generation sequencing (NGS) on
19 March 2015. ESPERITE welcomed Xitong Li, Ph.D., -former Director of
Bioinformatics at Verinata Illumina- to its expert team to advance molecular
diagnostics and translate breakthrough technology into high quality wider scope
and affordable genetic tests to top the predictive and personalized medicine
sector.
This acquisition avails ESPERITE advanced bioinformatics analytical processing
of NGS data for the detection and quantification of chromosomal numerical and
structural abnormalities, improving and expanding the performance and resolution
of the entire present and future genetic tests portfolio. ESPERITE will top the
genetic tests market by analyzing the entire genome for all chromosomal and sub-
chromosomal abnormalities applicable to pre-natal and post-natal genetic
analyses, identification of causes of genetic disorders and high resolution
tumor characterization.
ESPERITE acquired the InKaryo shares at a purchase price of USD 260,000, and
assume its obligations under its 2-year 6% USD 280,000 convertible bond.
ESPERITE is entitled to convert the convertible bond in ESPERITE shares at a
conversion price of EUR 2.99. ESPERITE paid USD 40,000 in cash and issued
73,530 new ESPERITE shares for this acquisition. The 73,530 shares were issued
on 9 April 2015. On 13 May 2015 ESPERITE issued 22,470 new ESPERITE shares to
fulfill the obligations of the convertible bonds in InKaryo Inc. which became
due in May 2015.
This new company in the group contributes to exclusive development of new
diagnostic products for which GENOMA controls the technology and owns the
intellectual property.
Investment in largest clinical genetic center.
A multimillion investment was announced on 29 February 2015 to build the largest
genetic platform for clinical diagnostics in Europe. A highly efficient NGS
platform with the capacity to process more than 100`000 samples per year. The
Swiss high technology laboratory, fully functional, passed all the validation
processes and is already operational for production and development of future
products.
International expansion is evaluated with the spread of satellite sequencing
platforms in the countries where ESPERITE operates, all connected to its NGS
Cloud.
Tranquility to the most complete CE-IVD fetal DNA NIPT test.
TRANQUILITY tops the trisomies detection market by combining the technologies of
IONA and InKaryo, the recently acquired company now part of the ESPERITE group.
TRANQUILITY's entire testing process for trisomies (sample collection,
preparation, sequencing, bioinformatics analysis and report) is compliant with
the European In Vitro Diagnostics Medical Devices Directive 98/79/EC and has
been certified by an independent body -UL International. TRANQUILITY, the only
CE-IVD certified genetic test for trisomies 21, 18 and 13 that provides, sexual
aneuploidies, microdeletions and fetal sex detection, now ready for mass market.
Succesfully launched in several countries, Tranquility already contributes to
the positive trend of growth that GENOMA is recording in the Group's key
markets: Spain, Italy, Hungary, Serbia, etc.
The NIPT test is more sensitive and specific than the current combined test,
providing accurate and reliable results to pregnant women. The benefits of NIPT
are a higher detection rate and lower false positive rate than existing
screening tests, giving pregnant women, their families and their doctors greater
confidence in the result. This further reduces the need for unnecessary invasive
follow-up tests and the associated anxiety and stress.
Genoma targets a population of 10 million newborns per year in Europe and The
Middle East.
Collaboration agreement with Premaitha Health for provision NIPT in Europe.
GENOMA signed an agreement with Premaitha Health plc ("Premaitha", AIM: NIPT)
under which GENOMA will have the right to use Premaitha's CE-IVD IONA® test for
its non-invasive prenatal testing (NIPT) TRANQUILITY®. Access to Premaitha's
test will allow GENOMA to apply the CE-IVD marking to its NIPT for trisomies
21, 18 and 13.
Serenity, the breast cancer and ovarian cancer risk screening test confirmed for
end of May 2015.
Genoma completed the full validation of SERENITY, the breast and ovarian cancer
risk screening test and, as scheduled, the test is ready for commercial launch
at the end of May 2015. Already some distribution agreements are established and
a marketing plan devised to support sales.
On 14 April 2015 ESPERITE announced its oncology genetic test SERENITY; the
risk-free, convenient, and accurate test that screens the entire coding regions
of the BRCA1 and BRCA2 genes, detecting all variants and reporting results in
less than 15 days. Sophia Genetics' bio-informatics platform ensures SERENITY
top analytical performance and the highest specificity and sensitivity in the
market. SERENITY provides the most comprehensive genetic information to
ascertain the risk of breast and ovarian cancer, and address it most
effectively. Early detection and precise identification of BRCA1 and BRCA2
variants saves lives. SERENITY empowers clients and doctors to take preventive
personalized actions best suited for the identified mutation, resulting in
vastly improved survival rates and better quality of life.
Genoma considers as market size the entire women population aged between 20 and
65.
Pipeline of new products.
Genoma has started to invest in R&D to enhance its pipeline of genetic tests.
These future products will allow Genoma to take full advantage of the ongoing
shift towards genetic screening and genetic diagnostic.
ESPERITE WILL DISCLOSE MORE ON ITS PIPELINE DURING THE AGM CONVENED ON JUNE
17(TH) 2015 IN AMSTERDAM.
Tackling autism with revolutionary genetic test.
REALITY, the new-generation genetic predisposition test for autism, was
announced on 5 February 2015. REALITY is pivotal for tackling autism because the
child can be tested at an early age, even at birth. This allows for early
intervention which is the most effective approach to alter how autism develops.
REALITY is a risk-free, convenient, affordable and reliable test, with results
available in less than 3 weeks. ESPERITE has acquired exclusive worldwide
distribution rights (excluding the United States) for IntegraGen's autism test,
the first of its kind marketed in the United States.
REALITY enables early life intervention helping physicians tailor therapy to the
child's genetic profile, lessening anxiety in parents. Early interventions under
the age of 3 - benefiting from the increased plasticity of the brain - stimulate
the brain receptors in autistic children to respond in a similar manner to a
child without autism. Early intervention improves communication skills, IQ
scores, cognitive and adaptive behavior, allowing children to become more
autonomous, follow mainstream education and, when adult, obtain employment and
live independently.
CRYOSAVE: Back on track.
CRYOSAVE (www.cryo-save.com), the Group's leading international stem cell
processing and cryo-preservation company and the largest stem cell bank in
Europe continued to have a stable new client intake. This is the result of an
improved and more proactive sales approach. The number of samples stored in Q1
2015 increased in comparison with last year's Q1. The percentage of customers
who also stored the cord tissue also increased.
THE CELL FACTORY: Pioneering clinical trials.
THE CELL FACTORY, the Group's R&D division, at the heart of the value chain,
between stem cells collection & storage and the existing and future treatments
that regenerative medicine is developing, implements its own proprietary new
technology for clinical grade production of autologous mesenchymal and stromal
stem cells. This technology allows for efficient production of stem cells at
large scale required for clinical translation in regenerative medicine.
THE CELL FACTORY pioneers first treatment worldwide of cerebral palsy using two
types of stem cells.
THE CELL FACTORY pioneers the first treatment worldwide of Cerebral Palsy using
two types of stem cells as announced on 23 February 2015. CRYOSAVE is the only
private cord blood bank sponsoring a GCP clinical trial according to GMP-ATMP
international guidelines. CRYOSAVE leads and sponsors a multicenter clinical
trial following GCP-ICH standards, for investigation of new treatment of
Cerebral Palsy using dual infusion of two types of stem cells derived from
umbilical cord blood and cord tissue processed by CRYOSAVE.
The clinical trial aims to demonstrate safety and preliminary efficacy of
sequential intravenous infusion of the ex vivo expanded mesenchymal stem cells
(MSC) derived from cord tissue and the cord blood stem cells. The study will
use, for the first time in clinical research, autologous MSC derived from
cryopreserved cord tissue. The clinical trial, sponsored by CRYOSAVE, will be
performed in collaboration with Professor Manuel Ramírez Orellana, the Principal
Investigator, and Professor Luis Madero, the Clinical Supervisor from the
University Hospital Niño Jesus in Madrid, Spain.
Frédéric Amar, Chief Executive officer, commented:
"Esperite is best-positioned to capitalize on the current confluence of
demographic and economic indicators: higher purchasing power, augmented
healthcare needs and a health-conscious aging population. Esperite elaborates
and makes its mass products affordable to society and national health systems,
profiting from the incremental processing and sequencing capacity to produce
higher throughput at lower costs.
Esperite combines cutting-edge technologies and scientific knowledge on its
automated processes to deliver the vital genetic information that enables
preventive and personalized medicine. Esperite's products and services empower
doctors and families to take a proactive and most effective approach to their
health".
ESPERITE WILL DISCLOSE MORE ON ITS STRATEGY DURING THE AGM CONVENED ON JUNE
17(TH) 2015 IN AMSTERDAM.
About ESPERITE
ESPERITE N.V., listed at Euronext Amsterdam and Paris (ticker: ESP) established
in 2000, operational in 40 countries.
To learn more about the ESPERITE group, or to book an interview with CEO
Frederic Amar: +31 575 548 998 - ir(at)esperite.com or visit the website at
www.esperite.com.
ESP PR Q1 19.05.2015:
http://hugin.info/143308/R/1922320/689131.pdf
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Source: Esperite N.V. via GlobeNewswire
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Datum: 19.05.2015 - 07:18 Uhr
Sprache: Deutsch
News-ID 394114
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