Press release Biocartis Group NV: Biocartis Reports Results of First Quarter of 2022: On Track to Deliver on Full-Year Guidance, Gross Margin on Products of 35%

Mechelen, BELGIUM


PRESS RELEASE: REGULATED INFORMATION

21 April 2022, 07:00 CEST

Biocartis Reports Results of First Quarter of 2022:
On Track to Deliver on Full-Year Guidance,
Gross Margin on Products of 35%


Mechelen, Belgium, 21 April 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 the outlook for the full year 2022.

Commenting on the Q1 2022 Business Update, Herman Verrelst, Chief Executive Officer of Biocartis,
said: Building on our strong fundamentals, we had a successful start into 2022. Our financial metrics for the first quarter clearly demonstrated our ability to scale. Our commercial cartridge volumes continued to increase globally, with nearly 2,000 Idylla™ instruments installed, increasing product revenues to EUR 10.1m in Q1 2022. The growth was particularly strong in oncology with 42% higher cartridge revenue compared to Q1 2021, whereas the revenue contribution for COVID-19 testing expectedly reduced by half year-on-year. The gross margin on product sales increased to 34.6%, a solid step-up from 16% in 2021. Unlike last year, we are producing at significantly higher capacity and productivity levels, as we leverage our fully automated second manufacturing line ML2. As a result, our operating cash burn was reduced to EUR 10.3m, compared to EUR 13.7m in Q1 2021. We believe we are clearly on track to achieve our stated targets for 2022 and to take a next step towards profitability.

Q1 2022 HIGHLIGHTS

  • Product revenue of EUR 10.1m (Q1 2021: EUR 8.6m), of which EUR 8.1m revenue from 79.8k cartridges sold:
    • Continued strong growth in oncology, led by the US, and an overall EUR 6.7m revenue in oncology, 42% higher than in Q1 2021
    • As expected, the contribution of cartridge revenues in infectious diseases reduced to 10% of total product revenues as COVID-19 testing demand continues to diminish
    • Average Sales Price (ASP) per commercial cartridge of EUR 114 in oncology and EUR 101 overall
    • 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 entire year 2021.
  • Operating cash burn1 of EUR -10.3m and cash position of EUR 37.3m (unaudited figure) end of Q1 2022. The cash position of EUR 53.0m on 31 December 2021 included EUR 6.0m, drawn on available credit facilities which has been repaid since. As of 31 March 2022, the available credit facilities of EUR 15.0m remained fully undrawn.
  • Publication of a large new study2 in the Journal of Clinical Pathology comparing the difference in turnaround time between in-house automated rapid PCR3-based EGFR analysis and Next-Generation Sequencing (NGS) by an external laboratory, showing that 6% of the 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 help identify which patients could benefit from curative-intent surgery, in particular liver transplantation.
  • Continued ramp-up of the fully automated ML2 manufacturing line with the transfer of the Idylla™ SARS-CoV-2 products to this line during Q1 2022.

OUTLOOK
Biocartis reconfirms its 2022 guidance towards driving profitable growth and expects to:

  • Achieve full year product revenue of EUR 50 - 55m, representing growth of 24% - 36% over full year 2021 revenue of EUR 40.5 million
  • Increase gross margins on product sales to 25% - 30%
  • Reduce the operating cash burn (EBITDA plus capital expenditure) by EUR 9.5m-13.5m to be between
    EUR 43m - 47m for FY22

FINANCIAL CALENDAR 2022

  • 13 May 2022                 AGM Biocartis Group NV
  • 1 September 2022        H1 2022 results
  • 10 November 2022        Q3 2022 Business Update

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More information:
Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
e-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 COVID-19, 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.
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.

Impact of the war in Ukraine
Biocartis has no sales in Ukraine. In Russia, Biocartis works through a local sales distributor who realized first commercial sales in H1 2021 following completion of first product registrations in Russia in Q1 2021. The impact to expected revenue for 2022 from Russian distributor sales that were projected prior to the start of the war, is not material. Supplier exposure is limited to 1 indirect supplier for Idylla™ instrument sub-parts who is based in Russia. Based on the current level of inventory on-hand and on various alternative sources of supply that were identified and are currently being assessed, Biocartis does not expect any material adverse impact on the continued supply of instruments.

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 EBITDA plus capital expenditure

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 Polymerase Chain Reaction or PCR is a fast and inexpensive technique used to amplify or copy small segments of DNA and used to detect genetic material such as biomarkers that drive cancer