Press Release Biocartis Group NV

Biocartis Meets 2019 Key Business Objectives

PRESS RELEASE: REGULATED INFORMATION                
Thursday 9 January 2020, 07:00 CET

Biocartis Meets 2019 Key Business Objectives

Mechelen, Belgium, 9 January 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces to have met its latest 2019 key business objectives which were focused on three performance indicators: the installed base expansion of its Idylla molecular diagnostics platform, the growth of its Idylla cartridge volume and its year-end cash position.

Based on non-audited numbers, Biocartis today reports:

• 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 per 31 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 to EUR 179m (non-audited number) versus the latest guidance of EUR 170-175m.

Additionally, Biocartis announced several operational achievements in 2019 that are expected to support further business growth, including amongst others:

• 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 in Japan. In October 2019, Nichirei Bio completed the registration of the Idylla Instrument and Idylla Console with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. With that, Nichirei Bio will now be able to offer the Idylla platform in combination with Idylla RUO² assays to local pathology laboratories in Japan, 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 in China 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 on 25 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