PRESS RELEASE: REGULATED INFORMATION
Thursday
Biocartis Meets 2019 Key Business Objectives
Based on non-audited numbers,
- Installed base –
Biocartis realized 337 new instrument placements in 2019, within range of the latest guidance of 325-350 new instrument placements. Biocartis’ installed base as per31 December 2019 consequently grew to 1,310 Idylla™ instruments. - Cartridge volume – In 2019,
Biocartis realized a commercial volume of 175K cartridges, representing a year-over-year increase of 32%. The achieved growth is within range of the latest guidance of 30-35%. - Cash position – As per
31 December 2019 , Biocartis’ cash position amounted toEUR 179m (non-audited number) versus the latest guidance ofEUR 170-175m .
Additionally,
- Execution US go-to market strategy – In
September 2019 ,Biocartis announced a new go-to market strategy for the US market under which Biocartis’ US direct sales team will drive commercialization going forward. Following the implementation of the new US go-to market strategy, the US direct sales team was strengthened and actions to address amongst others US market specific operational lessons learned in H1 2019 were implemented. - Execution
Japan go-to market strategy – Early 2019,Biocartis announced to have signed an agreement with Nichirei Biosciences1 (‘Nichirei Bio’) for the product registrations and distribution of the Idylla™ platform inJapan . InOctober 2019 , Nichirei Bio completed the registration of the Idylla™ Instrument and Idylla™ Console with thePharmaceuticals and Medical Devices Agency (PMDA) inJapan . With that, Nichirei Bio will now be able to offer the Idylla™ platform in combination with Idylla™ RUO2 assays to local pathology laboratories inJapan , whilst both partners are further progressing in vitro diagnostic (‘IVD’) registration preparations for the Idylla™ assays. - Execution
China go-to market strategy – In Q1 2019,Biocartis announced the completion of the joint venture with Wondfo3, aimed at the commercialization of the Idylla™ platform inChina with a first focus on the establishment of local manufacturing capabilities and product registrations. - Idylla™ test menu expansion – Successful CE-marking of the Idylla™ MSI Test, which was announced on
28 February 2019 and which further strengthened Biocartis’ colorectal cancer Idylla™ test menu, and launch of the liquid biopsy Idylla™ ctEGFR Mutation Assay (RUO3), which was announced on25 October 2019 . - New Idylla™ test menu partnerships – In 2019,
Biocartis announced two new partnerships with a focus on immuno-oncology. The first one is a collaboration agreement with Bristol-Myers Squibb Company that is focused on MSI testing in connection with immuno-oncology therapies and that allows for joint development and registrations of the Idylla™ MSI Test for use in a variety of indications, commercial settings and geographies. The second one is a master development and commercialization agreement with
Kite Pharma4 which aims at the development of molecular-based assays on the Idylla™ platform that are supportive to Kite’s therapies. - Idylla™ publications – In 2019, the performance of Idylla™ was the subject of over 45 Idylla™ publications, of which several were selected for publication at large scientific conferences such as ESMO5 (
European Society for Medical Oncology ), ASCO6 (American Society of Clinical Oncology ) and AMP7 (Association of Molecular Pathology ).
Herman Verrelst, Chief Executive Officer of
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Forward-looking statements
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2 Research Use Only, not for use in diagnostic procedures
3 Guangzhou Wondfo Biotech Co., Ltd. (‘Wondfo’, SHE: 300482) is a fast growing diagnostics leader in
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5
6 The ASCO Annual Meeting of the
7 AMP is the leading molecular diagnostics meeting that took place between
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