Earnings Release • Sep 2, 2021
Earnings Release
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Mechelen, Belgium, 2 September 2021 – 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 2021, prepared in accordance with IAS 34 'Interim Financial Reporting' as adopted by the European Union.
4 RUO = Research Use Only, not for use in diagnostic procedures 5 Biomarkers including gene fusions involving ALK1, ROS1, RET, NTRK1-2-3 as well as MET exon 14 skipping
6 Stransky et al. The landscape of kinase fusions in cancer. Nat Commun. 5, 4846, 2014; Mertens et al. The emerging complexity of gene fusions in cancer. Nat Rev Cancer 15, 371-381, 2015
8 MSI or Microsatellite Instability is the result of inactivation of the body's so-called DNA mismatch repair (MMR) system, which normally spontaneously corrects errors that occur during DNA replication 9 Flanders government agency for Innovation & Entrepreneurship
• New partnership with SkylineDx announced on 22 April 2021 for the development of SkylineDx's novel
1 Defined as the world excluding European direct markets, US, China and Japan 2 During Q1 2021, the Idylla™ platform, the Idylla™ BRAF Mutation Test (CE-IVD) and the Idylla™ EGFR Mutation Test (CE-IVD) completed registration in Russia, and the Idylla™ MSI Test (CE-IVD) completed registration in Taiwan, as such expanding the
commercial footprint for Biocartis' IVD medical devices. Post the reporting period, additional registrations were also completed in Taiwan 3 In China, Biocartis established a joint venture ('China JV') with Guangzhou Wondfo Biotech Co., Ltd (SHE: 300482), a fast-growing diagnostics leader in China. In Japan, Biocartis is collaborating with Nichirei Biosciences
7 A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). A 510(k) or Premarket Notification (PMN) with the US FDA is required when introducing a device into commercial distribution for the first time. Source: https://www.fda.gov/medical-devices/products-and-medical-procedures/device-approvals-denials-and-clearances, last consulted on 17 August 2021
proprietary Merlin Assay on Idylla™ aimed at predicting a patient's risk of nodal metastasis in melanoma.
The tables below show an overview of the key figures and a breakdown of operating income for H1 2021 and H1 2020. Consolidated financial statements and accompanying notes are included in Biocartis' half-year 2021 report that is available here on the Company's website.
10 Arcila ME, Yang S-R, Momeni A, Mata DA, Salazar P, Chan R, Elezovic D, Benayed R, Zehir A, Buonocore DJ, Rekhtman N, Lin O, Ladanyi M, Nafa K, Ultra-Rapid EGFR Mutation Screening Followed by Comprehensive Next-Generation Sequencing: A Feasible, Informative Approach for Lung Carcinoma Cytology Specimens with a High Success Rate., JTO Clinical and Research Reports (2020), doi: https://doi.org/10.1016/j.jtocrr.2020.100077., available online 18 July 2020; Arcila ME et al., Rapid EGFR Mutation Detection Using the Single-Institution Experience of 1200 Cases Analyzed by an In-House Developed Pipeline and Comparison with Concurrent Next-Generation Sequencing Results Idylla Platform, J Mol Diagn 2020, Published on 23 December 2020, 1-12; https://doi.org/10.1016/j.jmoldx.2020.11.009
11 Next Generation Sequencing 12 Behera et al. Circulating tumor DNA mutation as a prognostic marker in melanoma with brain metastasis. J Clin Oncol 39, 2021 (suppl 15; abstr e21560); Only the abstracts at the virtual AMP Europe congress (Association for Molecular Pathology, virtual congress taking place 14-18 June 2021) and ASCO (American Society of Clinical Oncology) in the US were screened 13 To replace CRBA Management BV, permanently represented by Christian Reinaudo, as independent director of the Company
| Key figures (EUR 1,000) | H1 2021 | H1 2020 | % Change |
|---|---|---|---|
| Total operating income | 23,057 | 17,606 | 31% |
| Cost of goods sold | -17,059 | -9,233 | 85% |
| Research and development expenses | -23,389 | -20,303 | 15% |
| Sales and marketing expenses | -7,740 | -7,931 | -2% |
| General and administrative expenses | -7,935 | -6,491 | 22% |
| Operating expenses | -56,132 | -43,958 | 28% |
| Operating result | -33,075 | -26,352 | 26% |
| Net financial result | -4,249 | -5,129 | -17% |
| Share in the result of associated companies | -101 | -195 | -48% |
| Income tax | 149 | 118 | 26% |
| Net result | -37,276 | -31,558 | 18% |
| Cash flow from operating activities | -33,752 | -24,526 | 38% |
| Cash flow from investing activities | -2,087 | -1,028 | 103% |
| Cash flow from financing activities | -3,518 | -3,456 | 2% |
| Net cash flow 1 | -39,357 | -29,010 | 36% |
| Cash and cash equivalents2 | 84,905 | 149,674 | -43% |
| Financial debt | 149,412 | 165,258 | -10% |
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 2021 and H1 2020
Operating income (EUR 1,000) H1 2021 H1 2020 % Change Collaboration revenue 2,640 4,746 -44% Idylla™ system sales 3,715 1,837 102% Idylla™ cartridge sales 14,749 9,584 54% Product sales revenue 18,463 11,421 62% Service revenue 748 530 41% Total revenue 21,851 16,697 31% Grants and other income 1,206 909 33% Total operating income 23,057 17,606 31%
| Product sales revenue (EUR 1,000) | H1 2021 | H1 2020 | % Change |
|---|---|---|---|
| Commercial revenue | 18,441 | 10,491 | 76% |
| Research & development revenue | 22 | 930 | -98% |
| Total product sales revenue | 18,463 | 11,421 | 62% |
After the fire that broke out at one of the warehouse facilities in Mechelen (Belgium) during the night of 30 July 2021, the Company has taken immediate actions to mitigate the loss of finished products and raw materials as well as the temporary unavailability of the high-throughput ML2 manufacturing line. Aiming to safeguard continued supply to customers as much as possible, actions included (i) the redirection of additional personnel and resources to the unaffected ML1 cartridge manufacturing line to temporarily increase production on this line, (ii) the placement of orders to replenish critical reagents lost in the fire from different suppliers to minimize production delay and (iii) the prioritization of oncology and partner project tests manufacturing. The latter consequently also reduces the Idylla™ SARS-CoV-2 testing volumes.
As a result, Biocartis is able to confirm a 40% cartridge volume growth target for 2021 (see 'Outlook' below), subject to the timely availability of reagent raw materials for Idylla™ cartridges in sufficient quantities and the full restart of the ML2 line, which is now expected by the 2nd half of September. Nevertheless, due to the already known delays in the supply of certain assay-specific reagents, certain products may still be temporarily unavailable to meet the entire customer demand and further mitigating action may be required after production resumes on ML2.
14 Respiratory Syncytial Virus
Alongside the ongoing development of a new technology on Idylla™ with the support of VLAIO, aimed at the offline customization of the Idylla™ cartridge15 to shorten development lead times for Idylla™ assays, Biocartis is currently also evaluating a new concept for a simplified, cost-efficient Idylla™ cartridge. In the mid to longer term, this should enable an accelerated reduction of the manufacturing cost of Idylla™ cartridges beyond the impact of continued volume growth and the resulting increased utilization of the available manufacturing capacity. The new cartridge concept reduces the complexity of the cartridge, and is ideally suited for infectious disease testing and certain oncology assays. The new concept is expected to run on the existing Idylla™ platform alongside the existing Idylla™ cartridge, which will continue to be used for those assays that are not compatible with the simplified, cost-efficient cartridge.
Post the reporting period, the feasibility of the new Idylla™ cartridge has been externally confirmed by a reputable global contract manufacturing organization. Subject to the successful design and manufacturing, the new Idylla™ cartridge concept is expected to facilitate the development of a highly competitive franchise of multiplex infectious disease assays with partners and may also be applicable to a number of oncology assays. The decision to invest in the development of new and existing Idylla™ assays using the new Idylla™ cartridge concept and in the accompanying manufacturing equipment, is still subject to completion of the concept design. As a result, the Company decided to review (the timing of) ongoing and future investments in the infectious disease and oncology assay menu.
As a reaction on the H1 2021 results and post-reporting period events, Herman Verrelst, Chief Executive Officer of Biocartis, commented: "After the very strong performance in H1 2021, both in terms of instrument placements as well as commercial cartridge volumes, the fire was obviously an unfortunate set-back. Although we cannot deny the fire has an impact, this event again showed the incredible resilience of our teams who have been working with relentless focus and dedication to limit the fall-out. I am proud to announce that we currently expect a smooth restart of the ML2 line by the second half of September 2021. This is also important considering the recent launch of the Idylla™ SARS-CoV-2/Flu/RSV Panel, the upgrade of our existing Idylla™ SARS-CoV-2 Test (CE-IVD) that now also includes Flu A/B and RSV. Ahead of a delayed flu season, this Panel is well positioned to guide healthcare providers in this complex landscape of respiratory infections in 2022. Furthermore, I am very excited to announce a possible break-through in our cartridge manufacturing with the ongoing evaluation of a new simplified, cost-efficient cartridge design which is expected to significantly lower manufacturing costs for a selection of our Idylla™ assays. Together with the ongoing development of a new technology on Idylla™ which aims to personalize Idylla™ assays while reducing development time and cost, this could prove to be a pivotal development towards sustainable growth in the years to come."
15 Previously referred to as the Idylla™ 'FLEX' technology, aimed to tap into new market opportunities with customized and personalized products
Biocartis will host a conference call with live webcast presentation today at 14:30 CET / 13:30 BST (UK) / 08:30 EDT (US) to discuss the H1 2021 results. Click here to access the live webcast. To participate in the questions and answers session, please dial 5-10 minutes prior to the start time the number +44844481975 (standard international), followed by the confirmation code 4866873. 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.
The condensed consolidated interim financial statements for the six-months' period ended 30 June 2021 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 2020. 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 2021 and the review opinion of the auditor are available on www.biocartis.com.
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Renate Degrave Head of Corporate Communications & Investor Relations Biocartis e-mail [email protected] tel +32 15 631 729 mobile +32 471 53 60 64 @Biocartis\_ www.linkedin.com/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. Idylla™ GeneFusion Assay, Idylla™ SARS-CoV-2 Test and SeptiCyte® RAPID on Idylla™: Patents US 7,700,339, 8,168,383, 8,481,279, 8,486,645, 8,232,060, 8,288,102, 8,377,642, 9,988,688, 9,523,130, 9,096,855, 10,526,661, 9,364,477, 9,539,254, 10,551,383 and pending US applications and all their respective foreign equivalents under license from Cell Signaling Technology, Inc. This product contains 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.
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. Forwardlooking 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.
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