| Source: Biocartis NV
Mechelen, BELGIUM
PRESS RELEASE: REGULATED INFORMATION
1 September 2022, 07:02 CEST
BIOCARTIS ANNOUNCES H1 2022 RESULTS
Affirms 2022 Outlook
35% growth in oncology cartridge revenues
Gross Margin on Products of 32%
Refinancing underway
Company will host a conference call with live webcast presentation today at 14:30 CEST / 13:30 BST (UK) / 08:30 EDT (US) to discuss H1 2022 results
Mechelen, Belgium, 1 September 2022 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces its business highlights and financial results for the first half of 2022, prepared in accordance with IAS 34 ‘Interim Financial Reporting’ as adopted by the European Union.
Commenting on the H1 2022 results and post-reporting period events, Herman Verrelst, Chief Executive Officer of Biocartis, said: “Our operational performance in H1 2022 marked a pivotal moment on our journey towards profitability: continued strong growth of our core oncology business translated into significantly higher gross margins. Cartridge revenue in our core oncology business grew by 35% year-on-year, and the gross margin on products increased to 32%. Despite the expected decrease of Idylla™ SARS-CoV-2 product sales, we almost quadrupled gross profit to EUR 6.6m during the first half of the year, fueled by increased average selling prices of cartridges in oncology and economies of scale in our cartridge manufacturing. We are on track to deliver on our objectives for the entire year, and also made important progress in securing future growth. We are particularly proud of the extended partnership with AstraZeneca for the development of a companion diagnostic for its blockbuster Tagrisso®. Furthermore, we were very pleased to announce that we entered into several financing arrangements with the support of certain holders of our convertible bonds. These will, upon successful completion, strengthen our cash position with approximately EUR 66m and fundamentally improve our financing structure.”
KEY MESSAGES H1 2022
REFINANCING
Today the Company announced a comprehensive recapitalization transaction (the ‘Transactions’) that will provide adequate capital to support the Company’s growth for the foreseeable future. The Transactions, which are supported by key existing investors, is a significant milestone for the Company and will provide for the following:
More information can be found in the press release here.
2022 OUTLOOK
As a result of a fading demand for COVID-19 testing, the product revenues for 2022 are projected to be around the lower end of the initial EUR 50-55m range, without any impact however on the previously stated expectations for gross margin on product sales and operating cash burn, which are maintained at:
Biocartis will host a conference call with live webcast presentation today at 14:30 CEST / 13:30 BST (UK) / 08:30 EDT (US) to discuss the H1 2022 results. Participants that want to follow the webcast presentation live, are invited to click on this link on the day of the event. Participants that also want to ask a question and/or attend the event over the phone, are required to register here in advance of the conference. After registration, each participant will be provided with dial-in numbers and a personal PIN. The conference call and webcast will be conducted in English. A replay of the webcast will be available on the Biocartis investors’ website shortly after.
Commercial highlights
Idylla™ test menu, partnerships & publications
Organizational and operational highlights
Financial highlights
KEY FIGURES H1 2022
The tables below show an overview of the key figures and a breakdown of operating income for H1 2022 and H1 2021. Consolidated financial statements and accompanying notes are included in Biocartis’ half-year 2022 report available here on the Company’s website.
1 Excludes the effect of exchange rate differences on the cash balances held in foreign currencies
2 Including EUR 1,2m of restricted cash in H1 2022 and H1 2021
IDYLLA™ TEST MENU OUTLOOK
POST-PERIOD EVENTS
FINANCIAL CALENDAR
AUDITOR STATEMENT
The condensed consolidated interim financial statements for the six-months’ period ended 30 June 2022 have been prepared in accordance with IAS 34 ‘Interim Financial Reporting’ as adopted by the European Union. They do not include all the information required for the full annual financial statements and should therefore be read in conjunction with the financial statements for the year ended 31 December 2021. The condensed consolidated interim financial statements are presented in thousands of Euros (unless stated otherwise). The condensed consolidated interim financial statements have been approved for issue by the Board of Directors. The statutory auditor, Deloitte Bedrijfsrevisoren/Reviseurs d’Entreprises, represented by Nico Houthaeve, has performed a review, which did not reveal any significant adjustments to the condensed consolidated interim financial statements. The interim financial report 2022 and the review opinion of the auditor are available on www.biocartis.com.
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More information:
Renate Degrave
Head of Corporate Communications & Investor Relations Biocartis
e-mail rd******@bi*******.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 one 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 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
3 Defined as the world excluding European direct markets, US, China and Japan
4 Partners providing test content so as to develop an Idylla™ version of their assay or test on the Idylla™ platform
5 EDTA represents Ethylenediaminetetraacetic acid, which is the anticoagulant used for most hematology procedures (like identifying and counting blood cells, blood typing, etc.). Source: ksmedical.com, last consulted on 24 August 2022
6 In addition to blood samples collected in PAXgene blood RNA tubes (per the manufacturer’s instructions), this test is now also able to process undiluted EDTA blood samples which are commonly used for most hematology procedures, with results available in about one hour
7 HepatoPredict will be distributed by Biocartis in Europe as a manual kit mainly addressing centralized expert laboratories, and the test may later be translated into a version on Biocartis’ rapid and easy-to-use molecular diagnostics platform Idylla™. HepatoPredict is a prognostic gene expression signature test to help identify which patients will benefit from curative-intent surgery, in particular liver transplantation
8 Research Use Only, not for use in diagnostic procedures
9 The Idylla™ SARS-CoV-2 Test (CE-IVD) and the Idylla™ SARS-CoV-2/Flu/RSV Panel (CE-IVD)
10 The contribution in H1 2022 mainly resulted from Idylla™ GeneFusion Assay (RUO) sales, as the Idylla™ GeneFusion Panel (CE-IVD) was only launched late in H1 2022, on 20 June 2022
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