BAGNEUX, France--(BUSINESS WIRE)--Regulatory News:
Genomic Vision (Paris:GV) (FR0011799907 – GV), a company specializing in the development of in-vitro diagnostic tests (IVD) for the early detection of cancers and genetic diseases and applications for life sciences research (LSR), today announced its 2017 annual results1.
Aaron Bensimon, Genomic Vision’s co-founder and Chairman, commented: “2017 was an important structural year for our various activities in order to establish ourselves on the research and diagnostics markets. Indeed, just a year after our breakthrough onto the new LSR segment, we have been able to put in place collaborative projects with major players in this field, such as AstraZeneca and Editas Medicine in the replication and quality control of gene editing respectively, two dynamic and much sought-after fields of research. Our first commercial agreement in China and the adoption of our technology by the Cologne Center for Genomics in Germany clearly attest to our molecular combing technology’s substantial appeal on this fast-growing market segment. Regarding in-vitro diagnostics, we have achieved solid breakthroughs in all our tests that have led to the first sale of an FSHD platform in China, a country of strategic interest for the development of our activities, the publication of positive interim results for our cervical cancer screening test (HPV test) and, more recently, the intensification of our partnership with Quest Diagnostics in spinal muscular atrophy (SMA). This expanded partnership could, if successful, represent a future source of additional revenue in the form of royalties on sales of SMA tests developed by Quest Diagnostics. All these achievements constitute a solid base for accelerating our growth in 2018 and beyond”.
1 Audited financial statements, reviewed by the Supervisory Board on March 20, 2018.
2017 annual results
|(in € thousands – IFRS)||2017||2016|
|Revenue from R&D collaboration with Quest Diagnostics||364||316|
|Sales of products and services||1,777||1,257|
|of which: life sciences research (LSR)||1,148||889|
|of which: in-vitro diagnostics (IVD)||629||368|
|Total revenue from sales||2,141||1,573|
|Total revenue from activity||3,612||3,366|
Net current operating expenses
Current operating income before share-based payments2
|Expenses relating to share-based payments||-419||-253|
|Other operating income and expenses||-605||-14|
Sales of products and services rose by 41% in 2017, to €1.8 million, and included:
€1.1 million generated on the LSR market segment (+29% compared to
2016) thanks to the sale of
3 FiberVision® platforms over the period and the gradual ramping up of sales of consumables and services, notably in the field of DNA replication;
€629 thousand recorded on the IVD market segment (+71% compared to
2016) from the sale of
2 FiberVision® platforms and the FSHD test in France, the launch of sales of the FSHD test in a clinical center in China and royalties paid by Quest Diagnostics, which markets this test in the United States.
Total revenue from sales increased by 36% in 2017, to €2.1 million, and includes €364 thousand in revenue from the R&D collaboration with Quest Diagnostics corresponding to the distribution throughout the year of license payments and to a first payment on a collaborative project in SMA.
Total revenue from activity was €3.6 million in 2017, an improvement of 7% compared to 2016, and takes into account other revenue of €1.5 million corresponding to tax credits (research tax credit, innovation tax credit, competitiveness and employment tax credit) and R&D subsidies.
Net current operating expenses (excluding share-based payments) totaled €11.7 million, stable compared to 2016, and include the following items in addition to the cost of sales:
- €4.5 million in R&D expenses, down 24% because of the refocus on higher added value projects and good cost control. These expenses mainly correspond to clinical trials on IVD products and the targeted development of new services and tools for the LSR market.
- €3.4 million associated with sales & marketing expenses, an increase of +31%, reflecting the investment made in Genomic Vision’s sales teams initiated in 2016 and pursued during the first half of 2017 to optimize Genomic Vision’s sales coverage to address the pharmaceutical industry, genome editing companies, academic and life sciences research centers and key clinical centers in IVD.
- €2.4 million in general expenses (-5%), in line with the cost-cutting plan undertaken by the Company.
2 Current operating income before share-based payments is defined and presented in Note 2.3.22, Segment Information, to the annual financial statements to December 31, 2017, which will be available online within the regulatory timeframe.
The current operating loss before share-based payments was €8.0 million at December 31, 2017, compared with €8.4 million a year earlier.
Once we include approximately €1.0 million in share-based payments and other operating expenses, mainly corresponding to non-recurring costs associated with a restructuring plan initiated during the second quarter of 2017, the operating loss was €9.1 million at December 31, 2017 vs. €8.7 million at the end of 2016. The net loss was €9.1 million at December 31, 2017 vs. €8.6 million a year earlier.
At December 31, 2017, Genomic Vision had 49 employees, compared with 63 at the end of 2016.
Financial structure at December 31, 2017
At December 31, 2017, Genomic Vision had cash and cash equivalents of €2.0 million, compared with €1.0 million at September 30, 2017. This cash position includes €1.4 million of 2016 research tax credit cashed-in in October 2017, the pre-financing of 2017 research tax credit for an initial tranche of €0.6 million, and €1.5 million from the drawdown of the fifth and sixth tranches of convertible notes with warrants. Net cash burn (excluding financial resources from the convertible notes with warrants) was €8.3 million in 2017.
Given the €6.5 million in additional financing available in the form of convertible notes with warrants, the terms of which have been renegotiated to provide greater flexibility, as well as the measures implemented to reduce operating costs, Genomic Vision has the necessary resources to continue its development on its target markets over the coming 12 months.
Frédéric Tarbouriech, CFO of Genomic Vision, added: “2017 was notably characterized by solid revenue growth of +36%, driven by the sale of 5 FiberVision® platforms and the gradual ramping up of associated services. This growth was achieved within the context of good control over our operating expenses, thanks to the implementation of operating cost-reduction measures and to the allocation of our financial resources to projects creating the greatest added value over the long term. Given the investments made in our sales teams, now sized to efficiently cover our main markets, we are confident our sales will continue to grow and our financial performances continue to improve”.
Dynamic development in 2017
During 2017, Genomic Vision continued its vigorous and targeted development, with applications on its versatile molecular combing platform that meet research requirements regarding the development of new cancer therapies, research and quality control for gene editing and the early diagnosis of cancers and genetic diseases:
Life Sciences Research (LSR) Market
- Technological cooperation with AstraZeneca in oncology
In May 2017, Genomic Vision signed a technological cooperation agreement with AstraZeneca as part of its research into new cancer treatments. Genomic Vision’s FiberVision® molecular combing platform is being used to evaluate the role of WEE1 tyrosine kinase inhibitors on cancer cells and study the repair of damage to DNA.
- Research project with Editas Medicine in gene editing
The Company has undertaken joint research work with Editas Medicine regarding the use of molecular combing to characterize the type and frequency of DNA rearrangements formed as a result of CRISPR/Cas9-mediated gene editing. This work was presented at the 3rd Cold Spring Harbor Laboratory meeting in New York in July 2017.
- Distribution agreement with APG Bio Ltd of China
In June 2017, the Company reached a commercial agreement with APG Bio Ltd, a leading player in the field of genomics in Asia, regarding the distribution of its solutions and services to research laboratories in China, Hong Kong and Macao.
- Launch of the “GV Store” e-commerce platform
At the end of the first half of 2017, Genomic Vision launched its GV Store e-commerce platform to enable international clients to order and pay online for products, notably consumables, and research services. This platform represents particularly effective support to the Sales and Marketing teams, and will facilitate the deployment of molecular combing in the research laboratory market segment whilst optimizing administrative processing.
- Adoption of molecular combing by the Cologne Center for Genomics (CCG)
In July 2017, after several months of testing of the FiberVision® platform, CCG, a European center of excellence in genetic research based in Cologne (Germany), decided to adopt molecular combing to identify new biomarkers in complex genetic disorders. The Cologne team is particularly interested in Factor H mutations with a view to assessing the risk associated with transplanting a kidney into patients suffering from Hemolytic Uremic Syndrome.
- Facioscapulohumeral dystrophy (FSHD test)
In October 2017, Genomic Vision initiated the marketing of the FSHD diagnostic assay in China with AmCare Genomics Laboratory, which has acquired a molecular combing platform and began marketing the FSHD test in a first clinical center.
Moreover, a new FiberVision® platform has been sold to the Timone hospital in Marseille to replace the previous platform.
- Human papilloma virus (HPV test)
Genomic Vision has presented the initial results of its clinical trial with its cervical cancer screening test (HPV test), conducted on 600 patients in the Czech Republic. Interim analysis of 126 patients has demonstrated that the integration of 14 high-risk human papillomavirus (HR-HPV) detected by molecular combing may offer a relevant indicator on the progress of pre-cancerous lesions and their degree of severity. These interim results were then presented at the Eurogin 2017 annual congress. Full results are expected during the second quarter of 2018.
- Ovarian and breast cancer (BRCA test)
The BRCA 1000 study, undertaken by Genomic Vision on the basis of DNA samples supplied by Quest Diagnostics, is continuing. The results, which are expected during 2018, will shape Quest Diagnostics’ strategic decisions regarding this test, in a market context where the analysis of susceptibility to hereditary breast cancer is no longer based solely on the BRCA1 and BRCA2 genes but on a panel of more than 30 genes.
- Spinal muscular atrophy (SMA test)
Throughout 2017, Quest Diagnostics and Genomic Vision continued their analysis work to identify new biomarkers that will enable healthy carriers of this devastating form of muscular atrophy to be detected. The aim is to determine a joint program to develop a diagnostic test for African-Americans, amongst whom this disease is more prevalent.
Expansion of the Company’s collaboration with Quest Diagnostics
Genomic Vision recently extended its collaboration with Quest Diagnostics within the framework of the SMA project. Following the promising initial results obtained in 2017, the two companies have agreed to accelerate their research program to potentially develop a molecular combing screening test. Should further tests be independently developed and marketed by Quest Diagnostics as a result of this research, Genomic Vision would receive royalties on sales.
- Supervisory Board
Mr. Neil Butler, member of the Supervisory Board, has retired and stood down from his duties as a member of the Supervisory Board and the Audit Committee, effective January 4, 2018.
- Executive Board
On December 12, 2017, the Supervisory Board appointed CFO Frédéric Tarbouriech as a member of Genomic Vision’s Executive Board, effective January 1, 2018.
Next financial publications*
● Q1 2018 revenue:
|Friday April 27, 2018|
● Shareholders’ Meeting:
|Tuesday June 19, 2018|
● H1 2018 results:
|Wednesday July 25, 2018|
● Q3 2018 revenue:
|Wednesday October 24, 2018|
* Press releases are published before the Euronext market opens.
ABOUT GENOMIC VISION
GENOMIC VISION is a company specialized in the development of diagnostic solutions for the early detection of cancers and serious genetic diseases and tools for life sciences research. Through the DNA Molecular Combing, a strong proprietary technology allowing to identify genetic abnormalities, GENOMIC VISION stimulates the R&D productivity of the pharmaceutical companies, the leaders of the diagnostic industry and the research labs. The Company develops a robust portfolio of diagnostic tests (breast, ovarian and colorectal cancers, myopathies) and analysis tools (DNA replication, biomarkers discovery, gene editing quality control). Based near Paris, in Bagneux, the Company has approximately 50 employees. GENOMIC VISION is a public listed company listed in compartment C of Euronext’s regulated market in Paris (Euronext: GV - ISIN: FR0011799907). For further information, please visit www.genomicvision.com
Member of CAC® Mid & Small and CAC® All-Tradable indexes
FORWARD LOOKING STATEMENT
This press release contains implicitly or explicitly certain forward-looking statements concerning Genomic Vision and its business.
Such forward-looking statements are based on assumptions that Genomic Vision considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the “Risk Factors” section of the reference document dated March 28, 2017, available on the web site of Genomic Vision (www.genomicvision.com) and to the development of economic conditions, financial markets and the markets in which Genomic Vision operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Genomic Vision or not currently considered material by Genomic Vision. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Genomic Vision to be materially different from such forward-looking statements.
This press release and the information contained herein do not constitute and should not be construed as an offer or an invitation to sell or subscribe, or the solicitation of any order or invitation to purchase or subscribe for Genomic Vision shares in any country. The distribution of this press release in certain countries may be a breach of applicable laws. The persons in possession of this press release must inquire about any local restrictions and comply with these restrictions.