Press release Biocartis Group SA: Biocartis announces its results

PRESS RELEASE: REGULATED INFORMATION

April 21, 2022, 07:00 CEST

Biocartis publishes its results for the first quarter of 2022:
On track to provide full year guidance,
Gross margin on products of 35%

Mechelen, Belgium, April 21th 2022 Biocartis Group NV (the “Company” or “Biocartis”), an innovative molecular diagnostics company (Euronext Brussels: BCART), today provides a business update for the first quarter of 2022 and outlook for the entire the year 2022.

Commenting on the Q1 2022 business update, Herman Verrelst, CEO of Biocartis,
mentioned: Building on our strong fundamentals, wWe have started 2022 successfully. Our financial measures for the first trimester clearly to proveD our ability to evolve. Our volumes of commercial cartridges cafter increase globally, with almost 2,000 Idylla™ instruments installed, increasing product income to EUR ten.1m in Q1 2022. Growth was particularly strong in oncology with cartridge revenue up 42% compared to the first quarter of 2021, while revenue contribution for COVID-19 testing as expected halved year on year. the gross margin on product sales increased for 34.6%, a groundId 16% increase in 2021. Unlike last year, we are productat significantly higher levels of capacity and productivity, as we leverage oyou are fully automated second production line ML2. As a result, our operating cash burn been reduced to EUR ten.3m, compared to EUR 13.7m in the first quarter of 2021. We believe us are clearly on track to achieve our goal targets for 2022 and take another step towards profitability.

Q1 2022 HIGHLIGHTS

  • Product revenue of €10.1 million (Q1 2021: €8.6 million), of which €8.1 million in revenue from 79,800 cartridges sold:
    • Continued strong growth in oncology, driven by the United States, and overall revenue of €6.7 million in oncology, 42% higher than in the first quarter of 2021
    • As expected, revenue contribution from cartridges in infectious disease has been reduced to 10% of total product revenue as demand for COVID-19 testing continues to decline
    • Average selling price (ASP) per commercial cartridge of 114 EUR in oncology and 101 EUR in total
    • 48 net new Idylla™ instruments placed, adding to a total global installed base of 1,960
  • Gross margin on product sales of 35%, compared to 16% for the whole of 2021.
  • Operating cash burn1 of -€10.3 million and a cash position of €37.3 million (unaudited figure) at the end of the first quarter of 2022. The cash position of €53.0 million as of December 31 2021 included €6.0 million drawn on available credit lines which have since been repaid. As of March 31, 2022, available credit facilities of €15.0 million remained entirely unused.
  • Publication of a major new study2 in the Journal of Clinical Pathology comparing runtime difference between in-house automated rapid PCR3-analysis based on EGFR and next-generation sequencing (NGS) by an external laboratory, showing that 6% of patients died before the NGS report was available.
  • New partnership agreement with Ophiomics (Portugal), initially focused on the commercialization of HepatoPredict™, a prognostic gene expression signature test to identify patients likely to benefit from curative surgery, in particular liver transplantation .
  • Continued ramp-up of the fully automated ML2 manufacturing line with the transfer of Idylla™ SARS-CoV-2 products to this line during the first quarter of 2022.

OUTLOOK
Biocartis reconfirms its 2022 profitable growth objectives and plans to:

  • Achieve a product turnover of 50 to 55 million euros in a full year, i.e. a growth of 24% to 36% compared to a turnover of 40.5 million euros in 2021
  • Increase gross margins on product sales to 25% – 30%
  • Reduce operating cash burn (EBITDA plus capital expenditures) by €9.5 million to €13.5 million to be between
    EUR 43 to 47 million for FY22

FINANCIAL CALENDAR 2022

  • May 13, 2022 AG Biocartis Group NV
  • September 1, 2022 2022 half-year results
  • November 10, 2022 Third Quarter 2022 Business Update

— TO FINISH —

More information:
Renate Degrave
Corporate Communication & Investor Relations Manager Biocartis
email [email protected]
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 real-time PCR (Polymerase Chain Reaction) system that delivers accurate and highly reliable molecular information from virtually any biological sample in virtually any environment. Biocartis develops and markets an ever-expanding menu of tests addressing key unmet clinical needs, with a focus on oncology, which represents the fastest growing segment of the MDx market globally. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as COVID-19, influenza, RSV and sepsis. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_.

Biocartis and Idylla™ are registered trademarks in Europe, USA States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks belonging to Biocartis. Please refer to the product labeling for the applicable intended uses for each individual Biocartis product.
This press release is not intended for distribution, directly or indirectly, in any jurisdiction where it would be illegal. Anyone reading this press release should inform themselves about and observe these restrictions. Biocartis assumes no responsibility for any violation of these restrictions by anyone. This press release does not constitute an offer or invitation to sell or buy 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 United States Securities Act of 1933, as amended.

Impact of the war in Ukraine
Biocartis has no sales in Ukraine. In Russia, Biocartis is working through a local distributor which achieved its first commercial sales in the first half of 2021 after the completion of the first product registrations in Russia in the first quarter of 2021. The impact on expected revenues for 2022 sales of Russian distributors which were projected before the start of the war, is not material. Supplier exposure is limited to 1 indirect supplier for subparts of the Idylla™ instrument which is based in Russia. Based on the current level of available inventory and the various alternative sources of supply that have been identified and are currently being evaluated, Biocartis does not expect any significant negative impact on the continued supply of instruments.

Forward-looking statements
Certain statements, beliefs and opinions contained in this press release are forward-looking and reflect the current expectations and projections of the Company or, as the case may be, of the directors or management of the Company regarding future events such as results of operations , financial position, liquidity, performance, outlook, 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, hypotheses and factors could adversely affect the results 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, may cause actual events, performance or results to differ materially 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. Furthermore, even if actual results or developments are consistent with the forward-looking statements contained in this press release, such results or developments may not be indicative of results or developments in future periods. No representation or warranty is made as to the accuracy or correctness of these forward-looking statements. Accordingly, the Company expressly disclaims any obligation or undertaking to issue updates or revisions to any forward-looking statements contained 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 as specifically required by law or regulation. Neither the Company, nor its advisers or representatives, nor any of its subsidiaries or the officers or employees of such persons warrant that the assumptions underlying these forward-looking statements are free from error and accept no responsibility for the future accuracy of forward-looking statements. statements contained in this press release or the actual occurrence of anticipated developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.


1 EBITDA plus investments

2 A. Finall et al., J Clin Pathol. 2022 Jan 18;jclinpath-2021-207987. doi: 10.1136/jclinpath-2021-207987. Online ahead of print
3 The polymerase chain reaction or PCR is a rapid and inexpensive technique used to amplify or copy small segments of DNA and used to detect genetic material such as biomarkers that lead to cancer

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