Press release Biocartis Group NV: Second Update on Fire Incident at Biocartis Warehouse

PRESS RELEASE: 17 August 2021, 07:00 CEST

REGULATED INFORMATION – INSIDE INFORMATION

Second Update on Fire Incident at Biocartis Warehouse

Mechelen, Belgium, 17 August 2021 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’) (Euronext Brussels: BCART) provides a second update regarding the impact on its production and 2021 Idylla™ commercial cartridge growth outlook, following a fire at one of the Company’s warehouse facilities in Mechelen, Belgium, during the night of 30 July 2021.

Update on production impact

A was issued on 2 August 2021, stating that the manufacturing equipment of the high-throughput ‘ML2’ cartridge production line located in the area adjacent to the affected warehouse was not damaged, but production at the ML2 line was temporarily suspended due to the need for structural repairs to the building and select supporting systems. Those repairs have already been initiated and are due to be completed by the second half of September 2021.

As previously communicated, the stock of Idylla™ instruments and consoles was not impacted. About half of the Company’s stock of finished Idylla™ cartridge products was still available to meet short term demand across most of the product portfolio. In terms of raw materials, the stock of plastic parts is unaffected, but a significant part of the stock of reagents used as raw materials in Idylla™ cartridge manufacturing was lost in the fire. Raw materials are available to continue cartridge manufacturing on the ML1 production line and orders have been placed to replenish critical reagents from different suppliers to minimize production delays.

Additional personnel and resources have temporarily been redirected to the ML1 line to increase production on this line, which was not affected by the fire. The Company is however running at considerably lower manufacturing capacity until production on the ML2 line is resumed, which is expected by the second half of September 2021, subject to critical reagents being supplied in sufficient quantities by then. The pandemic caused a global shortage of reagents and lead times for certain reagent supplies may be longer than usual, but the Company is working closely with its suppliers to minimize the impact. The Company is also collaborating with its customers and partners to serve their needs within the current capacity constraints, which the Company confirms to be temporary.

Impact of the fire on the 2021 outlook

This incident occurred at a time when the Company was gearing up manufacturing capacity to meet the strong growth in demand for its products seen in the first half of the year. Biocartis installed 189 new Idylla™ instruments in H1 2021 and almost doubled the cartridge volume year-over-year with 156k Idylla™ cartridges sold (+96%). Although Q2 2020 volumes were significantly impacted by the pandemic, the H1 2021 growth in oncology testing was strong and infectious diseases testing volumes remained robust at levels comparable to H2 2020 volumes.

Based on the commercial demand for the remainder of the year, as projected prior to the fire incident, the Company would have been in a position to confirm its earlier guidance of commercial cartridge growth of 40%-60%, with the high-end of the range depending on strong demand for the new Idylla™ SARS-CoV-2 Panel¹ during the upcoming flu season.

At this point in time however, the potential impact of the fire on the commercial cartridge volumes for H2 2021 cannot yet be reasonably estimated. Timely availability of reagents cannot yet be confirmed by suppliers. Also, with the constrained production capacity on the ML1 line, the Company has taken the decision to prioritize manufacturing of oncology tests and allocate a dedicated manufacturing capacity to partner projects. This may compromise SARS-CoV-2 testing volumes and the planned upcoming launch of the Idylla™ SARS-CoV-2 Panel. The Company will provide an update on 2 September 2021 in its H1 2021 results release.

The Company has in place customary insurance coverage, also covering business continuity, and does not expect any negative impact on its liquidity.

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More information:

Renate Degrave

Head of Corporate Communications and Investor Relations Biocartis

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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 continuously expanding test menu addressing key unmet clinical needs, with a focus in oncology, which represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as for SARS-CoV-2 and sepsis. More information: . Follow us on : @Biocartis_.



Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and 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

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

¹ Building upon the success of its Idylla™ SARS-CoV-2 Test (CE-IVD), the new Idylla™ SARS-CoV-2 Panel is expected to be launched as a CE-IVD and is expected to detect, in one single cartridge, SARS-CoV-2, Flu A/B and RSV (Respiratory Syncytial Virus) nucleic acids, with results in approx. 90 minutes