PRESS RELEASE: REGULATED INFORMATION
- H1 2021 results: Very strong growth with 156k commercial Idylla™ cartridges sold, almost twice as high as in H1 2020 (+96%) and 189 new Idylla™ placements in H1 2021;
- Outlook 40% cartridge growth still in reach following successful mitigation of the fire incident, but still subject to full restart of ML2 line by 2nd half September and timely availability of reagent raw materials for cartridges;
- Successful CE-IVD launch of Idylla™ SARS-CoV-2/Flu/RSV Panel after the reporting period;
- Cartridge manufacturing: New concept for simplified, cost-efficient cartridge manufacturing under evaluation.
H1 2021 RESULTS
- Commercial cartridge volume:
- 156k commercial Idylla™ cartridges sold, almost twice as high as in H1 2020 (+96%);
- Q1 2021 marked by 70% growth, followed by an even stronger +136% in Q2 2021;
- Robust growth in oncology across all regions; solid contribution from infectious diseases, comparable to the H2 2020 volumes against the backdrop of declining global COVID-19 testing volumes.
- Installed base:
- 189 new Idylla™ placements in H1 2021 (101 in H1 2020) mainly driven by demand in European and distributor1 markets as well as by content partners;
- Installed base of 1,770 Idylla™ instruments end of H1 2021;
- Average annualized cartridge consumption per Idylla™ instrument 209, in part reflecting high utilization for infectious disease testing.
- Regional performance:
Europe – Strong increase in new Idylla™ placements in European markets, leading to continued growth of cartridge volumes inEurope . Strongest growth in oncology, combined with the acquisition of new EU customers needing rapid SARS-CoV-2 testing for safe access to hospitals, events and travel.- US – Although Idylla™ placements slowed down in the US because of constrained hospital budgets following the pandemic, US commercial cartridge volumes grew by 150%. Growth driven by increased demand for oncology biomarker testing, although the return to pre-pandemic oncology biomarker testing volumes showed to be more disparate across the US. In infectious diseases, demand for SARS-CoV-2 testing in H1 2021 significantly down from 2020 levels.
- Distributor markets – Strong performance in terms of Idylla™ placements. Cartridge volume regained traction in oncology in all regions2.
China andJapan – Continued progress was made inChina andJapan 3. Registration of the Idylla™ instrument inChina is expected by the end of this year, while Idylla™ assay registrations are expected to follow earliest end of 2022 in both countries. Furthermore, during H1 2021, the progress in the local manufacturing set-up inChina was going well, with local manufacturing of first cartridge volumes needed for local registration of the assays expected in H1 2022.
- Idylla™ test menu, partnerships & publications:
- Encouraging first market demand for the Idylla™ GeneFusion Assay (RUO4), launched on
22 March 2021 . The Assay detects, in one single cartridge, a wide range of biomarkers covering all gene fusions5 considered to be relevant in cancer research6. - First oncology assay
US FDA submission forBiocartis with the 510(k)7 notification for the Idylla™ MSI Test for the detection of MSI8 and to aid in the differentiation between sporadic colorectal cancer and potential Lynch Syndrome on20 April 2021 . EUR 1.4 m grant from VLAIO9 announced on11 May 2021 , subject to the development of a new Idylla™ technology.- Post the reporting period, successful CE-IVD launch of the Idylla™
SARS-CoV-2/Flu/RSV Panel . The Panel detects SARS-CoV-2, Flu A/B and RSV nucleic acids in one single cartridge within approx. 90 minutes. Timing of the Emergency Use Authorization (‘EUA’) submission to theUS FDA to be decided. - New partnership with SkylineDx announced on
22 April 2021 for the development of SkylineDx’s novel proprietary Merlin Assay on Idylla™ aimed at predicting a patient’s risk of nodal metastasis in melanoma. - Expanded partnership with AstraZeneca announced on
4 May 2021 to improve access to rapid and easy-to-use Idylla™ EGFR testing products at selected hospital sites in European and global distributor markets. - 19 new Idylla™ publications, abstracts and posters were published in peer-reviewed journals during H1 2021, including the publication of two studies10 by
Memorial Sloan Kettering Cancer Center (‘MSKCC’,New York , US) concluding that Idylla™ EGFR testing (RUO) enables rapid assessment of the most common EGFR mutations with low sample input, even on different sample types, without compromising subsequent more comprehensive NGS11 testing, which can be useful in cases where EGFR mutation results were negative and further testing is needed. One abstract12 was presented at the ASCO Annual Meeting taking place virtually between4-8 June 2021 . One abstract on the SeptiCyte© RAPID on Idylla™ was presented at the 31st ECCMID (European Congress of Clinical Microbiology & Infectious Diseases ) congress
(9-12 July 2021).
- Encouraging first market demand for the Idylla™ GeneFusion Assay (RUO4), launched on
- Organizational and operational highlights:
- Shareholders’ Meetings – All agenda items approved during the ordinary shareholders’ meeting held on
14 May 2021 , including the re-appointment of Herman Verrelst, CEO of the Company, as director of the Company for a term of four years, and the appointment ofChristian Reinaudo as independent director of the Company for a term of three years13. All agenda items approved during the extraordinary general shareholders’ meeting held on4 June 2021 , including the renewal of the authorization to the Board of Directors to increase the share capital of the Company by up to 75% of the then current amount of the share capital, during a period of five (5) years. - Cartridge manufacturing – Transfer of the Idylla™ EGFR Mutation Test (CE-IVD) to the second cartridge manufacturing line (‘ML2’) completed during H1 2021. This concluded the transfer of Biocartis’ main oncology assays to ML2, which is a key driver of cost optimizations within the Company’s cartridge manufacturing activities. The resulting improvement of the gross margin on product sales was however offset by the global shortage of certain reagent supplies caused by the pandemic that forced lower than planned production volumes.
- Shareholders’ Meetings – All agenda items approved during the ordinary shareholders’ meeting held on
- Financial highlights:
- Total operating income – Total operating income amounted to
EUR 23.1m compared toEUR 17.6m last year. Product revenues increased by 62% fromEUR 11.4m in H1 2020 toEUR 18.5m in H1 2021. Within product sales, cartridge sales revenues increased by 54%. Idylla™ instrument sales revenues ofEUR 3.7m doubled on the back of 189 new instrument placements, 88 more than in H1 2020. Collaboration revenues amounted toEUR 2.6m and solely consisted of R&D services provided to partners. The decrease ofEUR 2.0m compared to H1 2020 is predominantly driven by the different timing of certain collaboration projects. - Idylla™ cartridge average sales price (ASP) - Idylla™ oncology cartridge ASP was stable at
EUR 104 . The ASP of the Idylla™ SARS-CoV-2 Test was lower than last year, in line with expectations and resulting in an overall ASP ofEUR 95 . - Gross margin – Gross margin on products of 8%, compared to 18% in H1 2020 as a result of the impact of the lower ASP of the Idylla™ SARS-CoV-2 Test. Furthermore, the gross margin was also temporarily impacted by higher COGS because production volumes were lower than expected as the pandemic caused a global shortage of reagent supplies. COGS also included the effect of hiring additional staff in anticipation of increasing volumes in the second half of the year.
- OPEX – Total operating expenses (excluding cost of sales) of
EUR 39.1m in H1 2021 increased fromEUR 34.7m in H1 2020, predominantly as a result of the planned acceleration and diversification of the Idylla™ test menu, both in oncology and in infectious diseases. - Net cash flow and cash position – The net cash outflow from operating and investing activities amounted to
EUR 35.8m in H1 2021 compared toEUR 25.6m in H1 2020. The increased outflow is attributable to (a) lower gross margin and (b) higher investment in net working capital and higher capital expenditure resulting from a higher number of Idylla™ instruments placed under reagent rental agreements. The cash and cash equivalents at30 June 2021 amounted toEUR 85.0m . - Revised credit facility – During H1 2021,
Biocartis entered into a new credit facility withKBC Bank , replacing the facilities withKBC Bank andBNP Paribas Fortis that came to maturity in 2020. This facility consists of aEUR 7.5m straight loan and aEUR 7.5m rollover credit line. To date, the new credit facility remains undrawn.
- Total operating income – Total operating income amounted to
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.
Key figures ( | 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
Operating income ( | 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 ( | 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% |
- Post-period events since
30 June 2021 :- Fire incident – See below under ‘Impact of the fire incident on the 2021 outlook’;
- Product registrations
Taiwan – Additional registrations for Idylla™ products have been completed inTaiwan ; - Launch Idylla™ SARS-CoV-2/Flu/RSV Panel (CE-IVD) – Successful CE-launch of the Idylla™
SARS-CoV-2/Flu/RSV Panel which detects SARS-CoV-2, Flu A/B and RSV14 nucleic acids in one single cartridge within approx. 90 minutes. Timing of the Emergency Use Authorization (‘EUA’) submission to theUS FDA to be decided; - Cartridge manufacturing – New concept of a simplified, cost-efficient cartridge manufacturing under evaluation, aimed at a significantly lower manufacturing cost for infectious disease and select oncology assays.
IMPACT OF THE FIRE INCIDENT ON THE 2021 OUTLOOK
After the fire that broke out at one of the warehouse facilities in
As a result,
SIMPLIFIED, COST-EFFICIENT CARTRIDGE CONCEPT
Alongside the ongoing development of a new technology on Idylla™ with the support of VLAIO, aimed at the off-line customization of the Idylla™ cartridge15 to shorten development lead times for Idylla™ assays,
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
OUTLOOK
- Commercial cartridge volume, Idylla™ installed base and cash position outlook: Despite the impact of the fire,
Biocartis confirms its 2021 guidance at 40% growth target for cartridge volumes:- Commercial cartridge volume: Targeting a year-over-year growth of 40%, or commercial cartridge volumes of 320k. This is subject to the timely availability of reagent raw materials for Idylla™ cartridges and the restart of the ML2 line by the 2nd half of September;
- Installed base: Targeting 300-350 new Idylla™ instrument placements;
- Cash position: Targeting at least
EUR 50m cash position at year-end, provided timely collection of insurance claims related to the fire incident.
- Idylla™ test menu outlook:
- ONCOLOGY TEST MENU:
- Lung cancer: Launch of the Idylla™ EGFR-BRAF+ Mutation Assay is being suspended awaiting the completion of the simplified, cost-efficient cartridge concept. Timelines will be communicated at a later stage;
- Breast cancer: Launch of the Idylla™
ABC (Advanced Breast Cancer) Assay in collaboration withLifeArc is expected in H2 2022.
- INFECTIOUS DISEASE (PARTNER) TEST MENU:
- Timing of the Emergency Use Authorization (‘EUA’) submission to the
US FDA for the Idylla™SARS-CoV-2/Flu/RSV Panel to be decided; - 510(k) clearance with the
US FDA of the SeptiCyte® RAPID on Idylla™ (Immunexpress ) is pending.
- Timing of the Emergency Use Authorization (‘EUA’) submission to the
- DEVELOPMENT OF A NEW SIMPLIFIED, COST-EFFICIENT CARTRIDGE CONCEPT: The concept design of the new simplified, cost-efficient cartridge concept is still under evaluation. This will impact the decision to invest in manufacturing equipment and the actual development of new and existing Idylla™ assays based on this concept. Outcomes of the assessment and associated development timelines will be communicated at a later stage.
- ONCOLOGY TEST MENU:
FINANCIAL CALENDAR
10 November 2021 Q3 2021 Business Update- 24 February 2022 2021 full year results
- 31 March 2022 Publication 2021 annual report
AUDITOR STATEMENT
The condensed consolidated interim financial statements for the six-months’ period ended
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More information:
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e-mail rdegrave@biocartis.com
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mobile +32 471 53 60 64
About
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 Defined as the world excluding European direct markets, US,
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
3 In
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.
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
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
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
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 (
13 To replace
14 Respiratory Syncytial Virus
15 Previously referred to as the Idylla™ ‘FLEX’ technology, aimed to tap into new market opportunities with customized and personalized products
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