Biocartis Group NV

Regulatory Filings • Jan 7, 2019

Biocartis Announces Achieving its 2018 Key Business Objectives

Mechelen, Belgium, 7 January 2019 – Biocartis Group NV (the 'Company' or 'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces to have achieved its 2018 key business objectives.

Biocartis' key business objectives for 2018 were focused on three performance indicators: installed base expansion of its Idylla™ molecular diagnostics platform, cartridge volume growth and the Company's year-end cash position. Based on non-audited numbers, Biocartis now reports meeting or exceeding these business objectives:

• Installed base Biocartis realized 326 new instrument placements in 2018, exceeding the latest guidance of 300 new instrument placements. Biocartis' installed base as per 31 December 2018 consequently grew to around 970 Idylla™ instruments.
• Cartridge volume In 2018, Biocartis realized a commercial volume of approx. 133k cartridges, in line with the latest guidance of 130k – 135k cartridges. Biocartis' 2018 commercial cartridge volume represents a year-overyear increase of approx. 87%.
• Cash position As per 31 December 2018, Biocartis' cash position amounted to EUR 64m (non-audited number) versus the latest guidance of around EUR 55m. No drawdowns on the Company's multiple purpose credit facility of EUR 27.5m were made as per year-end 2018.

Other key achievements in 2018 that are expected to support further business growth, include amongst others:

• US Successful initial roll-out of the Idylla™ platform in the US during the first full year of commercialization in that market, attracting reference customers such as Memorial Sloan Kettering Cancer Center (New York) and Dartmouth – Hitchcock Medical Center (New Hampshire);
• China Announcement of joint venture with Wondfo for commercialization of the Idylla™ platform in China;
• Japan Selection of commercialization partner for Japan, resulting into signing of a distribution agreement with Nichirei Bioscience as announced on 7 January 2019;
• Menu of molecular diagnostic tests Continued menu expansion with the launch of the Idylla™ MSI Assay (RUO¹ );
• Test content partnerships Expansion of the collaboration with Genomic Health Inc. into the field of urology with the planned development of an Idylla™ Oncotype DX GPS test and potentially additional cancer tests. Progression of the Idylla™ Oncotype Breast Recurrence Score® test towards launch; and
• Partnerships with pharmaceutical partners New agreement with AstraZeneca aimed at demonstrating that Idylla™ can overcome the long turnaround time for lung cancer biomarker results.

Herman Verrelst, Chief Executive Officer of Biocartis, comments: "I am pleased we can announce today that we have achieved our key 2018 objectives. The growth in instrument installed base and the year-over-year ramp-up of cartridge volume are clear indicators of the commercial growth curve that we are on. We have significantly strengthened our global commercial footprint in 2018. With the recent signing of the commercialization agreement for the Japanese market we now have a commercial network in all major markets worldwide. As we furthermore continue to grow the assay menu on the Idylla™ platform and expand our partner network, Biocartis is in a solid position to execute upon its mission to offer rapid and easy molecular diagnostic solutions aimed at enabling faster and more accurate treatment decisions for oncology patients across the globe."

Biocartis will publish its 2018 full year results and 2019 guidance on 28 February 2019. Next to a live webcast that day, Biocartis will also host a Capital Markets Day tailored for institutional investors, research analysts and sector journalists to provide amongst others an update on the Company's test menu strategy. On 10 January 2019, Biocartis will present at the 37th Annual J.P. Morgan Healthcare conference in San Francisco, California (US) at 10:30 PST /19:30 CET.

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¹ Research Use Only, not for use in diagnostic procedures.

More information:

Renate Degrave Manager Corporate Communications & Investor Relations e-mail rdegrave@biocartis.com tel +32 15 631 729 mobile +32 471 53 60 64 @Biocartis\_ www.linkedin.com/Biocartis

About Biocartis

Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology. This area represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.

Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis trademark and logo and the Idylla™ trademark and logo are used trademarks owned by Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.

Forward-looking statements

This press release may contain forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements speak only as of the date of this press release. Biocartis expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements.