ESPERITE Trading Update. Q1 confirms strategy and forecasted growth with Genoma

May 19, 2015 Group News

ESPERITE N.V. Trading Update. Q1 confirms strategy and forecasted growth with Genoma

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 17TH 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 17TH 2015 IN AMSTERDAM.

 





About ESPERITE

ESPERITE group, listed at Euronext Amsterdam and Paris, is a leading international company in regenerative and predictive medicine since 2000, operational in 40 countries with a network of 6,000 clinics worldwide. ESPERITE serves clients in its state-of-the-art lab facilities in Geneva coupled with ultra-modern processing and storage facilities in Belgium, Switzerland, Germany, Dubai, South Africa and Portugal. Its family stem cell bank, CryoSave, stores almost 275,000 samples from umbilical cord blood and cord tissue.

To learn more about the ESPERITE group, or to book an interview with CEO Frederic Amar: +31 575 548 998 – ir@esperite.com or visit the websites at www.esperite.com and www.genoma.com.

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