BCART Biocartis Group NV

PRESS RELEASE: REGULATED INFORMATION10 November 2021, 07:00 CET

BIOCARTIS Q3 2021 BUSINESS UPDATE

Mechelen, Belgium, 10 November 2021 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today provides a business update for the third quarter of 2021 and the outlook for remainder of the year 2021.

Commenting on the Q3 2021 Business Update, Herman Verrelst, Chief Executive Officer of Biocartis, said: “During Q3 2021, customer demand in oncology continued to grow strongly and was no longer disrupted by the pandemic in most parts of the world. This strong demand could however only be partly met because of the two-month production stop on our high-throughput cartridge manufacturing line, caused by the fire end of July. Customer orders were definitely there to maintain the growth rate of 96% we achieved in H1 2021, but limited production capacity confined cartridge volume growth to 29% in Q3 2021, and to 69% year-to-date. The shortage of reagents which already held us back in serving our customers’ needs during the first half of the year, now also disrupts the replenishment of raw materials lost in the fire. The entire team is working hard to maximize production output and I believe that we are on track to significantly reduce the order backlog by the end of the year. Before the fire, we were on track to deliver record cartridge volume growth in 2021, but I am nevertheless proud that our outlook of 40% is still within reach, providing that reagent supply will allow us to produce as planned for the remainder of the year.”

Q3 2021 HIGHLIGHTS

• Commercial cartridge volume:
  • 29% commercial cartridge volume growth in Q3 2021 year-over-year and 69% growth year-to-date, despite the customer order backlog caused by the fire
  • Strongly growing demand in oncology across Europe, and a consistent contribution of the Idylla™ SARS-CoV-2 Test (CE-IVD) to total volumes
  • Confirmed recovery of oncology volumes in distributor markets1 that recorded the strongest growth of all regions in Q3 2021
  • Steadily growing US cartridge volumes in oncology while basic Idylla™ SARS-CoV-2 Test volumes continue to come down
• Idylla™ installed base:
  • Installed base expansion on track, 43% more Idylla™ instruments placed year-over-year
  • Pace of new Idylla™ installations in the US is picking up after a slow H1 2021
• Idylla™ test menu and partnerships:
  • Successful CE-IVD launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel on 2 September 2021
  • First Idylla™ SARS-CoV-2/Flu/RSV Panel (CE-IVD) cartridge volumes sold in European markets
• Financial:
  • End of Q3 2021, Biocartis’ cash position amounted to EUR 64m (unaudited figure), not yet including insurance cover for damages caused by the fire

Commercial highlights

• Commercial cartridge volume – Global commercial cartridge demand continued to grow strongly but could only be partly fulfilled as a direct consequence of the fire incident of 30 July 2021. Cartridge manufacturing had to be suspended on the high-throughput manufacturing line ‘ML2’ for nearly two months. The time needed to replenish available stocks of raw materials still causes order backlogs across a variety of Idylla™ assays. Commercial cartridge volume in Q3 2021 nevertheless grew 29% year-over-year and average selling prices remained stable. Despite the customer order backlog, cartridge volume growth was particularly strong in Europe and in certain distributor markets where the pandemic impact on oncology testing is clearly fading out. As expected, the demand for the Idylla™ SARS-CoV-2 Test continued to reduce in the US2. In contrast, the demand for COVID-19 access testing in Europe with this Test remained robust, complemented by initial supply of the newly launched Idylla™ SARS-CoV-2/Flu/RSV Panel (CE-IVD).
• Installed base – The expansion of the Idylla™ installed base remained on track. The pace of new Idylla™ instrument placements picked up again in the US, compared to a slower H1 2021. Year-to-date Idylla™ instrument placements in Europe and in distributor markets are equally well ahead of 2020 numbers.
• Regulatory update distributor markets – During Q3 2021, the registration of the Idylla™ NRAS-BRAF Mutation Test (CE-IVD) and the Idylla™ KRAS Mutation Test (CE-IVD) was completed in Taiwan.

Test menu and partnership highlights

• Idylla™ SARS-CoV-2/Flu/RSV Panel – Successful CE-IVD launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel on 2 September 2021. The Panel detects SARS-CoV-2, Flu A/B and RSV nucleic acids in one single cartridge3.

Organizational and operational highlights

• Fire incident – On 23 September 2021, Biocartis announced the restart of its high-throughput ML2 cartridge manufacturing line following the completion of the repairs and subsequent control and quality related procedures leading to the successful restart of the ML2 line in the night of 21 September 2021. Following a fire that broke out at one of the Company’s warehouse facilities in Mechelen (Belgium) during the night of 30 July 2021, production on the ML2 line had been temporarily suspended. With the ML2 line now restarted, the Company is continuing efforts to secure the supply of certain assay-specific reagents, which remains a key condition for achieving the Company’s commercial cartridge volume guidance of 40% growth in 2021 (see under ‘Outlook’).

Financial highlights

• Cash position – End of Q3 2021, Biocartis’ cash position amounted to EUR 64m (unaudited figure), not yet including insurance cover for damages caused by the fire.

Outlook

The shortage of certain reagents caused by the pandemic is disrupting the timely replenishment of sufficient inventory. This still causes certain Idylla™ products to be temporarily unavailable to meet the entire customer demand, even after resuming production on the ML2 cartridge manufacturing line. Providing that this customer order backlog can be substantially reduced by the end of the year, Biocartis confirms its 2021 guidance at 40% growth target for its cartridge volumes:

• Commercial cartridge volume: Targeting a year-over-year growth of 40%, or commercial cartridge volumes of 320k. This is still subject to the timely availability of reagent raw materials for Idylla™ cartridges;
• Installed base: Targeting 300-350 new Idylla™ instrument placements;
• Cash position: Targeting at least EUR 50m cash position at year-end, provided timely collection of insurance claims related to the fire incident and potentially including a drawdown of available credit on the Company’s multipurpose credit facility to rebuild sufficient safety stock of raw materials and finished products.

Financial calendar 2022

• 24 February 2022          2021 full year results
• 31 March 2022              Publication 2021 annual report
• 21 April 2022                Q1 2022 Business Update
• 13 May 2022                 Annual General Shareholders’ meeting Biocartis Group NV
• 1 September 2022         H1 2022 results
• 10 November 2022        Q3 2022 Business Update

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More information: Renate DegraveHead of Corporate Communications & Investor Relations Biocartise-mail        rdegrave@biocartis.com tel             +32 15 631 729 mobile       +32 471 53 60 64

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/flu/RSV and sepsis. More information: www.biocartis.com. Follow us on Twitter: @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. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. The Idylla™ SARS-CoV-2 Test and Idylla™ SARS-CoV-2/Flu/RSV Panel contain SuperScript™ III Reverse Transcriptase and is provided subject to a license under patents or patent applications owned by or licensed to Life Technologies Corporation, which license is limited to the human diagnostic field and research field and specifically excludes applications in forensics (including human identity testing). The SuperScript™ III trademark is owned by Life Technologies Corporation.

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. 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 statementsCertain 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 Defined as the world excluding European direct markets, US, China and Japan2 The Idylla™ SARS-CoV-2 Test was CE-marked on 10 November 2020 and in August 2020, Biocartis submitted a notification of intent to distribute and request for ‘Emergency Use Authorization’ (EUA) from the US FDA for the Idylla™ SARS-CoV-2 Test3 And delivers results within approx. 90 minutes

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