PRESS RELEASE:REGULATED – INSIDE INFORMATION
Key messages
- Commercial cartridge volume: Year-on-year Q1 growth of 68% in commercial cartridge volume demonstrating the growth potential within a well-established customer base across all regions.
Europe remains the largest contributor led by very strong performance in Northern, Central and Western European markets, partially fueled by pro-active stock orders in light of the COVID-19 pandemic. - Installed base: Slower than expected installed base expansion across markets in Q1 2020 due to the global COVID-19 pandemic, with main impact suffered in Southern European, the US and RoW1 markets.
- Partnerships: Successful partnership expansions in oncology with AstraZeneca, with a study on liquid biopsy testing using the Idylla™ ctEGFR Mutation Assay (RUO2), and with Bristol Myers Squibb Company (BMS), with a new project aimed at pursuing the registration of the Idylla™ MSI test as a companion diagnostic3 (CDx) test in metastatic colorectal cancer (mCRC) in
China , as well as a successful expansion of the partnership in infectious diseases withImmunexpress Pty Ltd ('Immunexpress' ) for the co-commercialization inEurope of the SeptiCyte® RAPID Test on Idylla™, which recently received CE-marking. - Menu of tests: Development of the Idylla™ SARS-CoV-2 test, the virus that causes COVID-19, for rapid and easy testing of individuals with flu-like symptoms. When used in combination with recently CE-marked IVD SeptiCyte® RAPID Test4 on Idylla™, this testing solution has the unique potential to identify patients with severe disease, as recent data5 indicate that sepsis is the most frequently observed complication in COVID-196.
- Appointment new CFO:
Biocartis announces the appointment ofJean-Marc Roelandt as the new Chief Financial Officer (‘CFO’) of the Company with immediate effect.Jean-Marc Roelandt is a Senior executive with an established track record of more than 25 years as CFO in globally active publicly listed companies. Prior to joiningBiocartis , he was CFO of MDxHealth. - Cash position: Biocartis’ cash position end Q1 2020 amounted to
EUR 170.1m (unaudited figure).
COVID-19 impact on full year 2020 guidance
Due to the COVID-19 pandemic, new Idylla™ instrument placements slowed down towards end Q1 2020 as access to hospitals was restricted. As there is limited visibility on when these restrictions will be lifted and as Idylla™ instrument sales may temporarily further suffer from budgetary restrictions across all healthcare systems in the aftermath of the global pandemic, the Company is suspending its guidance on instrument placements in 2020 and will provide an update as soon as normal business activity resumes. Furthermore,
The cash position is still targeted to be in the range of
Commenting on the Q1 2020 Business Update, Herman Verrelst, Chief Executive Officer of
Commercial highlights
- US commercialization – Continued expansion in installed base in US markets was demonstrated at the start of Q1 2020, underlining the success of the direct US sales strategy where positive customer feedback resulted in the attraction of new reference Idylla™ users that presented several Idylla™ posters and abstracts at the global USCAP conference in
March 2020 (see below). During Q1 2020, the US represented over 40% of new Idylla™ instrument placements, however growth of both installed base expansion and commercial cartridge volume stalled due to the COVID-19 impact, as access to hospitals and labs was restricted. - European commercialization – European direct markets realized robust cartridge volume growth during Q1 2020 predominantly driven by outperformance in Northern, Central and Western European markets.
- RoW commercialization – Commercial cartridge volume growth in RoW distribution markets continued in Q1 2020 driven by increased use of Idylla™ on the existing RoW installed base of which the expansion however was impacted due to the COVID-19 disturbance in commercial activities of RoW distribution partners. During Q1 2020, new market authorizations were also obtained for the Idylla™ MSI Test in
Colombia andCanada and for the Idylla™ EGFR Mutation Test inArgentina .
Menu and partnership highlights
- Idylla™ SARS-CoV-2 test – On
23 April 2020 ,Biocartis announced the development of a SARS-CoV-2 test, the virus that causes COVID-19, on Idylla™. The test will be based on the Idylla™Respiratory (IFV-RSV) Panel 7 that received 510(k) clearance by theUS FDA on5 September 2017 and is being designed to detect SARS-CoV-2 from respiratory samples such as nasopharyngeal swabs. Upon regulatory approval, the Idylla™ SARS-CoV-2 test is targeted to help healthcare providers manage the COVID-19 pandemic through rapid and easy testing of individuals with flu-like symptoms. In addition, the Idylla™ SARS-CoV-2 test may be used in combination with the recently CE-marked IVD SeptiCyte® RAPID Test8 on Idylla™ to facilitate management of patients within the hospital intensive care unit (ICU). When used together, this combined testing solution on Idylla™ has the unique potential to identify patients with severe disease, as recent data9 indicate that sepsis is the most frequently observed complication in COVID-1910.Biocartis develops the Idylla™ SARS-CoV-2 test with support from multiple undisclosed partners as part of a joint commitment to respond to the COVID-19 pandemic. Subject to a successful ‘Emergency Use Authorization’ by theUS FDA , launch of the Idylla™ SARS-CoV-2 test is expected in H2 202011. TheUS FDA 510(k) clearance of the SeptiCyte® RAPID Test on Idylla™ is expected along the same timelines. - Partnership AstraZeneca – On
22 January 2020 ,Biocartis announced that it entered into a master collaboration agreement with AstraZeneca, a global science-led biopharmaceutical company (LON/STO/NYSE: AZN). The scope of the new master collaboration agreement enables collaborative development and commercialization projects betweenBiocartis and AstraZeneca, such as but not limited to, CDx development projects that may cover any type of indication or biomarker. The first project in that context is a study focused on evaluating if liquid biopsy testing using the Idylla™ ctEGFR Mutation Assay (RUO) could provide further benefits to tissue-based EGFR molecular testing. New BMS Immuno-Oncology MSI Project inChina – On5 March 2020 ,Biocartis announced a new project under its existing collaboration with Bristol-Myers Squibb Company (NYSE: BMY), a global biopharmaceutical company. The existing collaboration aims at the potential registration and use as a CDx of the Idylla™ MSI test in connection with immuno-oncology therapies of Bristol-Myers Squibb. The initial focus under the collaboration is to achieve registration inthe United States of the Idylla™ MSI test as a CDx test in metastatic colorectal cancer (mCRC). Bristol-Myers Squibb andBiocartis have now agreed to add a new project under their collaboration which pursues the registration of the Idylla™ MSI test as a CDx test in mCRC12 in the People’sRepublic of China .- Expansion
Immunexpress partnership – On26 March 2020 ,Biocartis announced the co-commercialization agreement withImmunexpress of the newly CE-marked IVD SeptiCyte® RAPID Test on Idylla™, in whichBiocartis will lead commercialization inEurope as exclusive distributor of the SeptiCyte® RAPID Test, whileImmunexpress will lead commercialization in the US. The SeptiCyte® RAPID Test is a rapid, host-response13 test that distinguishes sepsis from non-infectious SIRS (systemic inflammatory response syndrome) and is expected to provide actionable results in about one hour14. Recent data15 indicate that sepsis is the most frequently observed complication in COVID-1916. - European performance studies – During Q1 2020, seven17 new Idylla™ performance publications18 were issued in
Europe . All Idylla™ studies demonstrated excellent performance of Idylla™ compared to other methods, in combination with the ease of use and fast turnaround time of the Idylla™ platform. The studies included, amongst others, a feasibility study19 on the Idylla™ NRAS-BRAF Mutation Test20 to research the direct use of thyroid FNA (Fine Needle Aspirate) samples as a Rapid On site Molecular Evaluation (ROME ) solution for the rapid and easy detection of NRAS and BRAF mutations without having to send out the samples to specialized, centralized labs. - USCAP abstracts & posters – During the global annual pathology conference USCAP, that took place in
Los Angeles, CA (US) between 2 -4 March 2020 , four Idylla™ abstracts and posters21 were published by key oncology opinion leaders, including amongst othersDartmouth-Hitchcock Medical Center (Lebanon, New Hampshire , US),Vitro Molecular Laboratories (Miami, Florida , US), theUniversity of New Mexico (Albuquerque, New Mexico , US) and theWilliam Osler Health System (Brampton, Ontario, Canada ). The respective Idylla™ abstracts and posters showed strong data of Idylla™ assays (RUO) including several studies that used the Idylla™ EGFR Mutation Assay (RUO), which demonstrated reliable and rapid EGFR testing to be used to complement conventional NGS testing.
Operational and financial highlights
- Appointment new CFO – On
27 January 2020 ,Biocartis announced thatEwoud Welten , the Company’s CFO, has decided to resign fromBiocartis and to pursue an opportunity inthe Netherlands , closer to his home and family. The Company now appointsJean-Marc Roelandt as the new CFO of the Company with immediate effect.Jean-Marc Roelandt is a Senior executive with an established track record of more than 25 years as CFO in globally active publicly listed companies. With a focus on M&A, capital market transactions and the implementation of adequate financial management infrastructure in dynamic and fast growing companies, he built up a solid expertise in various industries. Prior to joiningBiocartis , he was CFO of MDxHealth, a healthcare company that provides actionable genomic information to personalize the diagnosis and treatment of cancer. - COVID-19 business continuity – To ensure business continuity during the COVID-19 pandemic, measures were implemented to ensure safe working conditions for all employees as well as to ensure continued commercial production of Idylla™ cartridges on the two manufacturing lines in
Mechelen (Belgium ) during Q1 2020. - Cash position - Biocartis’ cash position end Q1 2020 amounted to
EUR 170.1m (unaudited figure).
Outlook
- COVID-19 impact on full year 2020 guidance: see above.
- Test menu outlook:
- Colorectal cancer menu – Subject to further feedback from
US FDA interaction,US FDA 510(k) submission of the Idylla™ MSI Test is expected by end 2020 and the timing of theUS FDA submission of PMA (Pre-Market Approval) application for the Idylla™ RAS tests is being assessed; - Lung cancer menu – Further development of the Idylla™ GeneFusion Assay towards expected RUO launch by end 2020;
- Breast cancer menu – Start of the clinical validation studies of the Idylla™ IVD Oncotype DX Breast Recurrence Score® test in
France andGermany is expected in 2020; - Infectious disease partner menu –
US FDA 510(k) clearance for the SeptiCyte® RAPID Test on Idylla™ is expected by Q3 2020 and US FDA Emergency Use Authorization for the Idylla™ SARS CoV-2 test is expected in H2 2020.
- Colorectal cancer menu – Subject to further feedback from
- Cash position: Targeted cash position in the range of
EUR 110m by 2020 year-end.
Financial calendar 2020
8 May 2020 Annual and Extraordinary Shareholders’Meetings Biocartis Group NV - 3 September 2020 H1 2020 results
- 12 November 2020 Q3 2020 Business Update
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More information:
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About Biocartis
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 RoW = Rest of the World. RoW is defined as the world excluding European direct markets, US,
2 RUO = Research Use Only, not for use in diagnostic procedures
3 An IVD companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Source:
4 Developed in collaboration with
5 Zhou et al., Clinical course and risk factors for mortality of adult inpatients with COVID-19 in
6 Sepsis developed at a median of 9 days (7–13) after illness onset among all patients, followed by ARDS (12 days [8–15]), acute cardiac injury (15 days [10–17]), acute kidney injury (15 days [13–19.5]), and secondary infection (17 days [13–9])
7 Legally acquired in 2018 from
8 Developed in collaboration with
9 Zhou et al., Clinical course and risk factors for mortality of adult inpatients with COVID-19 in
10 Sepsis developed at a median of 9 days (7–13) after illness onset among all patients, followed by ARDS (12 days [8–15]), acute cardiac injury (15 days [10–17]), acute kidney injury (15 days [13–19.5]), and secondary infection (17 days [13–9])
11 Subject to interactions with the
12 mCRC = Metastatic colorectal cancer
13 Host-response based tests focus on measuring biomarkers that are indicative of the response of a patient’s immune system to an infection rather that measuring pathogens that are the cause of the infection
14 Moreover, SeptiCyte® RAPID not only discriminates sepsis from SIRS but also correlates with viral sepsis infection, versus procalcitonin (PCT) which increases with severity of bacterial but not viral infection and is also a non-specific marker of inflammation
15 Zhou et al., Clinical course and risk factors for mortality of adult inpatients with COVID-19 in
16 Sepsis developed at a median of 9 days (7–13) after illness onset among all patients, followed by ARDS (12 days [8–15]), acute cardiac injury (15 days [10–17]), acute kidney injury (15 days [13–19.5]), and secondary infection (17 days [13–9])
17 Of which two studies were published in epub, ahead of print in Q2 2020
18 De Luca C et al., ‘Rapid On-site Molecular Evaluation in thyroid cytopathology: A same-day cytological and molecular diagnosis’. Diagn Cytopathol. Diagn Cytopathol. 2020 Apr;48(4):300-30. Epub
19 De Luca C et al., ‘Rapid On-site Molecular Evaluation in thyroid cytopathology: A same-day cytological and molecular diagnosis’. Diagn Cytopathol. Diagn Cytopathol. 2020 Apr;48(4):300-30. Epub
20 The Idylla™ NRAS-BRAF Mutation Test is intended for use on FFPE samples (Formalin Fixed, Paraffin Embedded) and not for use on FNA samples. Please refer to the
21
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