PRESS RELEASE: REGULATED INFORMATION
Based on non-audited numbers for 2022,
- Idylla™ product revenues of
EUR 45m are fully in line with the latest guidance and includedEUR 35.8m from cartridge sales (+13% year-on-year) andEUR 9.2m from instrument sales and rentals (+4% year-on-year). Within cartridge sales, the core oncology business grew 30% year-on-year, while SARS-CoV-2 cartridge sales were 49% lower than in 2021 against the backdrop of fading COVID-19 testing needs. - Gross margins on product sales of 34%, a strong increase from 16% in 2021 and well in excess of the guidance of at least 30%.
- Operating cash burn (EBITDA plus capital expenditure) of
EUR 38.5m , significantly better than the previously expected range ofEUR 41m - 43m and a sizeable reduction ofEUR 18.1m fromEUR 56.6m in 2021.
Herman Verrelst, Chief Executive Officer of
In 2022,
- In
February 2022 ,Biocartis announced a new partnership with Ophiomics2 for the commercialization of HepatoPredict, a prognostic gene expression signature test to help identify which patients with Hepatocellular Carcinoma (HCC) will benefit from curative-intent surgery, in particular liver transplantation. InOctober 2022 ,Biocartis started the commercialization of the HepatoPredict test (developed by Ophiomics) as a CE-IVD marked prognostic diagnostic manual kit that supports the decision of liver transplantation in patients. - In
June 2022 ,Biocartis announced a double milestone with the selling of its one-millionth commercial Idylla™ cartridge and the placement of its 2,000th Idylla™ instrument since its commercial launch. - Also in
June 2022 ,Biocartis launched its CE-marked, fully automated Idylla™ GeneFusion Panel (CE-IVD) which detects in one single cartridge ALK, ROS1, RET and METex14 skipping, a wide range of actionable targets for fast treatment decisions in non-small cell lung cancer (NSCLC). - End of
June 2022 ,Biocartis announced a new partnership agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) aimed at the development and applicable pre-market notification with theUS FDA of a novel CDx test on the Idylla™ platform, for use with Tagrisso® (osimertinib3). - In
September 2022 ,Biocartis announced the start of the commercialization inEurope of SkylineDx’s innovative Merlin Assay as a CE-IVD marked manual kit aiming to predict a melanoma patient’s risk of nodal metastasis and may help safely forgo an invasive surgery. - Also in
September 2022 ,Biocartis announced its comprehensive recapitalization transaction aimed at securing adequate capital to support the Company’s growth for the foreseeable future.
Additionally, in 2022, a record of 42 new publications on Idylla™ products were issued by key opinion leaders across the globe validating the high performance of Idylla™ products, bringing the total number of Idylla™ publications to 166 end of 2022. Publications included several studies with Idylla™ tests such as the Idylla™ EGFR Mutation Test (CE-IVD) and the Idylla™
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More information:
Head of
e-mail rdegrave@biocartis.com
tel +32 15 631 729
mobile +32 471 53 60 64
About
With its revolutionary and proprietary Idylla™ platform,
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.
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 CDx = Companion diagnostics. A companion diagnostic (CDx) test is a test used as a companion to a therapeutic drug that helps predict if a patient is likely to respond to a treatment or not
2 A
3 AstraZeneca’s third-generation EGFR-TKI (tyrosine kinase inhibitor) treatment
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