Press release Biocartis Group NV: BIOCARTIS ANNOUNCES 2021 RESULTS
AND 2022 OUTLOOK
PRESS RELEASE: REGULATED INFORMATION24
February 2022, 07:00 CET
BIOCARTIS
ANNOUNCES 2021 RESULTS AND
2022
OUTLOOK
Mechelen, Belgium,
24 February
2022 – Biocartis Group NV (the ‘Company’
or ‘Biocartis’), an innovative molecular diagnostics company
(Euronext Brussels: BCART), today announces its operational
highlights and financial results for 2021, prepared in accordance
with IFRS as adopted by the European Union as well as selected post
period events and its outlook for 2022.
Commenting on the
2021 results and
2022 guidance, Herman Verrelst, Chief
Executive Officer of Biocartis, said:
“2021 has proven to be an eventful year. A fire and a shortage of
raw cartridge materials significantly troubled our cartridge
manufacturing, but our teams managed through the situation
extremely well and minimized impact to our loyal customers. We were
undeniably held back in our ambition to grow much faster.
Nonetheless, we were able to deliver a robust 40% volume growth in
commercial cartridges for the full year and built out an installed
base of close to 2,000 Idylla™ instruments, while exceeding EUR 50m
in revenue from core activities. Simultaneously, 2021 was a year of
menu expansion: we launched two new tests and signed new
partnerships, including the partnership in melanoma with SkylineDx
for high-value test content on Idylla™. We also made important
progress in the US, where we submitted our first oncology assay
with the US FDA and our partner Immunexpress obtained US FDA 510(k)
clearance for SeptiCyte® RAPID on Idylla™. Finally, the continued
positive feedback from our customers and new studies re-confirmed
the value of Idylla™ to patients. These growth drivers are all
important as we pursue our mission to bring more, better and faster
molecular diagnostics to patients across the globe, through the
offering of tests across the entire spectrum of cancer care, from
prognosis to surveillance, and in infectious diseases. Looking
ahead at 2022, we will continue to grow revenues and lay a solid
foundation for profitable growth as we scale our manufacturing
capabilities and significantly reduce the cash burn while
developing, together with partners, new high value tests on
Idylla™.”
KEY MESSAGES
2021 RESULTS
Total operating income:
- Revenue from product sales and
Idylla™ system services amounted to EUR 42.2m, a year-over-year
increase of 27%
- Total revenue of EUR 48.3m, up 12%
from 2020
- Total operating income of EUR 54.9m
compared to EUR 55.6m in 2020
Commercial
cartridges:
- Growth of the commercial cartridge
volume by 40% to 323k cartridges
- Strong growth in oncology of 25% year-on-year, particularly in
European and distributor markets1. US volumes were stable as
COVID-19 testing volumes declined, while a strong increase of the
Average Sales Price (ASP) led to double-digit growth of oncology
revenue
- Consistent demand for the Idylla™ SARS-CoV-2 testing products2,
shifting from the US to Europe compared to 2020
Installed base:
- 331 net new Idylla™ instruments
placed in 2021
- Global installed base of 1,912
Idylla™ instruments as at 31 December 2021
Partnerships:
- New partnership agreement with
SkylineDx for the development of the Merlin Assay on Idylla™, aimed
at predicting a patient’s risk of nodal metastasis in melanoma
- Expanded partnership with
AstraZeneca to improve access to rapid and easy-to-use Idylla™ EGFR
testing products at selected hospital sites in European and global
distributor markets
- Post the reporting period, on 8
February 2022, Biocartis announced the signing of an agreement with
Ophiomics which will initially focus on the commercialization of
HepatoPredict™, a prognostic gene expression signature test to help
identify which patients will benefit from curative-intent surgery,
in particular liver transplantation.
Idylla™ test
menu:
- Launch of the Idylla™ GeneFusion
Assay (RUO3) as a rapid lab workflow solution for gene fusion
testing of ALK, ROS1, RET, NTRK 1/2/3, as well as MET exon 14
skipping which is increasingly used in research related to multiple
cancer types including lung cancer, thyroid cancer and others
- First oncology assay US FDA
submission with the 510(k) submission4 of the Idylla™ MSI
Test5
- Launch of the Idylla™
SARS-CoV-2/Flu/RSV Panel (CE-IVD) which detects, in one single
cartridge, SARS-CoV-2, Flu A/B and RSV6 nucleic acids, with results
in approximately 90 minutes
- Received US FDA 510(k) clearance
for SeptiCyte® RAPID7 on Idylla™8 (CE-IVD, US FDA 510(k)),
developed under the partnership with Immunexpress9
China &
Japan commercialization:
- In China, submission of the Idylla™ Instrument and Console with
the China NMPA10 completed and initial feedback received from the
NMPA regulatory agency
- In Japan, Nichirei Biosciences submitted in Q4 2021 the
registration applications of the Idylla™ MSI Test, the Idylla™ KRAS
Mutation Test and the Idylla™ NRAS-BRAF Mutation Test with the PMDA
regulatory agency
Cash position:
- 2021 was a year of exceptional
investment, including the upgrade of the menu to comply with the
new IVDR (In Vitro Diagnostics Regulation11) and various
initiatives to expand and diversify the test menu and to further
improve our technological capabilities. The cash burn for the year
amounted to EUR 70.1m and was in line with expectations, except for
the insurance claim for fire damages of EUR 4.6m, of which EUR 3.8m
is yet to be collected
- Cash and cash equivalents amounted
to EUR 53.5m at 31 December 2021. The cash position included EUR
6.0m drawn on short-term credit facilities
2022 OUTLOOKIn
2022, the Company will continue to focus on driving profitable
growth and expects to:
- Grow product revenue by 24-36% to
between EUR 50m and EUR 55m
- Achieve a gross margin on product
sales of between 25% and 30%
- Reduce the operating cash burn
(EBITDA plus capital expenditure) with EUR 9.5m-EUR 13.5m to
between EUR 47m-EUR 43m
Biocartis will host a
conference call with live webcast presentation today at 14:30 CET /
13:30 BST (UK) / 08:30 EST (US) to discuss the full year 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 +44 8444819752, followed by the
confirmation code 9959967. 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
- Global – The number of commercial
cartridges sold in 2021 grew by 40% to 323k from 230k in 2020.
Oncology volumes were driven by a strong customer demand in all
regions, resulting in +96% growth in the first half of 2021.
Cartridge volumes also included a continued contribution from the
Idylla™ SARS-CoV-2 Test that was comparable to the second half of
2020. Nevertheless, the global supply of reagents was already
disrupted in the first half of 2021, and the fire at one of the
Biocartis facilities at the end of July 2021 only added to a
constrained production capacity on the Company’s high-throughput
manufacturing line (ML2). The production on the ML2 line had to be
halted for two months and the replenishment of raw materials
restrained the growth of the commercial cartridge volume for the
full year to 40% as customer demand could only be partly met. The
pace at which new Idylla™ instruments were installed equally slowed
down because of insufficient cartridge supply needed to onboard new
customers. Net new placements of 331 instrument were nevertheless
in line with the stated objective for the year and strengthened the
global installed base to 1,912 Idylla™ instruments. The ASP of
commercial cartridges in 2021 amounted to EUR 96. As expected, the
ASP for Idylla™ oncology assays of EUR 105 was diluted by lower
prices for the Idylla™ SARS-CoV-2 Test as compared to 2020. Sales
related to the Idylla™ SARS-CoV-2 products amounted to 14% of total
revenues in 2021.
- Europe – Sales in Europe exceeded
expectations with a year-over-year overall growth of 69%, driven by
continued high growth in oncology as well as a strong sale of the
Idylla™ SARS-CoV-2 tests to new, large customers in Norway, the UK
and Italy.
- US – In the US, the
commercialization of Idylla™ products to new customers has not
entirely normalized across the country. The Company took the
opportunity to restructure its US commercial operations, putting in
place new sales leadership to reorientate, expand and retrain its
commercial staff. This restructuring, in combination with the
overall market environment, temporarily paused new Idylla™
instrument placements and cartridge volumes in oncology stabilized.
However, the ASP significantly increased, leading to robust
double-digit growth of oncology cartridge revenue. As expected,
demand for the Idylla™ SARS-CoV-2 Test reduced from the strong
demand in the fourth quarter of 2020 which was characterized by a
capacity constrained testing market.
- Distributor markets – Of all
geographies, in oncology, the distributor markets grew the fastest
2021. Except for a few smaller countries, demand bounced back
strongly from 2020, including in Latin-America that was hit hard by
the pandemic. Initial commercial sales were accomplished in Russia
and Taiwan, following product registrations in these markets in Q1
202112. Additionally, further to new UK regulations, market
authorizations for the Idylla™ platform and oncology assays have
been granted by the UK MHRA regulatory agency in December 2021.
Furthermore, in November 2021, the Idylla™ SARS-CoV-2 Test was
submitted with the UK CTDA and the registration is expected in Q1
2022. Finally, in December 2021, Kazakhstan granted the
registration of the Idylla™ platform and oncology assays.
- Japan commercialization – After
successfully completing the clinical performance evaluation studies
in Japan, Biocartis’ partner Nichirei Biosciences submitted in Q4
2021 the registration applications of the Idylla™ MSI Test, the
Idylla™ KRAS Mutation Test and the Idylla™ NRAS-BRAF Mutation Test
with the Japanese PMDA agency. Initial Idylla™ assay registrations
in Japan are expected earliest end of 2022.
- China commercialization – Following
the submission of the Idylla™ Instrument and Console with the China
NMPA early 2021, Biocartis received initial feedback. The set-up of
local manufacturing capability is nearing completion. Initial
Idylla™ assays registrations in China are however not expected
before late 2023 due to changed regulatory requirements regarding
clinical validation.
TEST MENU AND PARTNERSHIP
HIGHLIGHTS
- Oncology: In 2021, Biocartis
progressed both in its test menu and partnerships:
- Idylla™ GeneFusion Assay – In March
2021, Biocartis launched the Idylla™ GeneFusion Assay (RUO) as a
rapid lab workflow solution for gene fusion testing of ALK, ROS1,
RET, NTRK 1/2/3, as well as MET exon 14 skipping which is
increasingly used in research related to multiple cancer types
including lung cancer, thyroid cancer and others. A CE-IVD launch
of the Idylla™ GeneFusion Assay is expected in 2022 (see ‘menu
outlook’);
- 510(k) submission Idylla™ MSI Test
– In April 2021, Biocartis announced its first US FDA submission of
an oncology assay with the 510(k) submission of its Idylla™ MSI
Test for use as an in vitro diagnostic device intended for the
identification of microsatellite instability (MSI) status in
colorectal (colon) cancer (CRC) to aid in the differentiation
between sporadic CRC and potential Lynch syndrome;
- Partnership SkylineDx – Also in
April 2021, Biocartis announced the signing of a partnership
agreement with SkylineDx which targets the development of their
novel proprietary test, the Merlin Assay, on the Idylla™™ platform,
which is aimed at predicting a patient’s risk of nodal metastasis
in melanoma. The CE-IVD launch of the manual kit of the Merlin
Assay in collaboration with SkylineDx for commercialization in
Europe by Biocartis is expected this year (see ‘outlook’
below);
- Partnership AstraZeneca – In May
2021, Biocartis announced its expanded partnership with AstraZeneca
to improve access to rapid and easy-to-use Idylla™ EGFR testing
products at selected hospital sites in European and global
distributor markets;
- VLAIO grant – Also in May 2021,
Biocartis announced the EUR 1.4 million grant it received from
VLAIO, the Flanders organization for Innovation &
Entrepreneurship, for the ongoing development of a highly
innovative technology to be deployed on the Idylla™ platform aimed
at enabling the off-line customization of the Idylla™
cartridge;
- Partnership Ophiomics – Post the
reporting period, on 8 February 2022, Biocartis announced it had
signed an agreement with Ophiomics, a Lisbon (Portugal) based
biotech company developing a precision medicine portfolio focused
on liver cancer. The collaboration will initially focus on the
commercialization of HepatoPredict™, a prognostic gene expression
signature test to help identify which patients will benefit from
curative-intent surgery, in particular liver transplantation.
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 the Idylla™
platform;
- Partnership GeneproDx – RUO launch
of the ThyroidPrint© on Idylla™ in collaboration with GeneproDx is
expected in 2022 (see ‘outlook’ below);
- Partnership LifeArc – RUO launch of
the Idylla™™ ABC (Advanced Breast Cancer) Assay in collaboration
with LifeArc is expected in 2022 (see ‘outlook’ below).
- Infectious diseases: In 2021
Biocartis further strengthened its infectious disease menu:
- Launch Idylla™ SARS-CoV2/Flu/RSV
Panel – In September 2021, Biocartis announced the launch of its
Idylla™ SARS-CoV2/Flu/RSV Panel (CE-IVD) which detects, in one
single cartridge, SARS-CoV-2, Flu A/B and RSV nucleic acids, with
results in approximately 90 minutes;
- 510(k) clearance for SeptiCyte®
RAPID – In November 2021, Biocartis announced the US FDA granted
510(k) clearance for SeptiCyte® RAPID (CE-IVD, US FDA 510(k)) which
runs on the Idylla™ platform13 and was developed under the
partnership with Immunexpress. The SeptiCyte® RAPID is a fully
automated, rapid host-response test14 that distinguishes sepsis
from infection negative systemic inflammation in patients suspected
of sepsis, providing actionable results in approximately 1 hour,
enabling physicians to optimize patient management decisions. In
2022, SeptiCyte® RAPID PLUS, an assay based on SeptiCyte® RAPID
that can also distinguish between bacterial and viral infections,
is expected to be launched as a CE-IVD (see ‘outlook’ below).
- Idylla™ performance data: During
2021, 34 new Idylla™ papers were published, bringing the total
number of Idylla™ papers published end of 2021 to 123. Idylla™’s
excellence along with the performance of Idylla™’s EGFR15 testing
solutions was emphasized through several studies and abstracts:
- In February 2021, Biocartis
announced the publication of two studies16 by Memorial Sloan
Kettering Cancer Center (‘MSKCC’, New York, US) on the use of
Biocartis’ Idylla™ EGFR Mutation Assay (RUO) as a rapid first-line
testing method before using next-generation sequencing (NGS). Both
studies concluded that Idylla™ EGFR testing enables rapid
assessment of the most common EGFR mutations with low sample input,
even on different sample types, without compromising subsequent
more comprehensive NGS testing17;
- In November 2021, Biocartis
announced the publication of a study18 which concluded that the
Idylla™ platform contributes to improving patient management
decisions for patients with non-small cell lung cancer (NSCLC)
through the faster screening of EGFR mutations.
ORGANIZATIONAL
AND OPERATIONAL HIGHLIGHTS
- Fire incident – During the night of
30 July 2021, a fire broke out at one of the warehouse facilities
in Mechelen (Belgium), causing the loss of finished products and
raw materials as well as the temporary unavailability of the
high-throughput ML2 manufacturing line. Cartridge manufacturing was
suspended on the ML2 line for nearly two months and the time needed
to replenish available stocks of raw materials caused order
backlogs across a variety of Idylla™ assays in the second half of
the year.
- Cartridge manufacturing – Transfer
of the Idylla™ EGFR Mutation Test (CE-IVD) to the ML2 line was
completed during H1 2021, as such concluding the transfer of
Biocartis’ main oncology assays to the fully automated ML2 line.
This is a key driver of cost optimizations within the Company’s
cartridge manufacturing activities and was demonstrated by a 33%
gross margin on assays produced on the ML2 line, despite
lower-than-expected production volumes on this line throughout
2021. The Idylla™ SARS-CoV-2 Test and Idylla™ SARS-CoV-2/Flu/RSV
Panel are being transferred to the ML2 line in the first half of
2022 and this is expected to further contribute to absorbing fixed
manufacturing costs awaiting full capacity utilization of the ML2
line that can produce up to 1m tests annually.
- Ordinary and Extraordinary General
Shareholders’ Meetings – During the ordinary shareholders’ meeting
held on 14 May 2021, the shareholders of the Company approved all
items on the agenda of the annual shareholders' meeting including
the approval of the remuneration policy and report, the
re-appointment of Herman Verrelst, Chief Executive Officer of the
Company, as director of the Company for a term of four years, and
the re-appointment of Christian Reinaudo as independent director of
the Company for a term of three years. Since there was no
deliberation and voting on the items on the agenda of the
extraordinary shareholders’ meeting because the attendance quorum
for such meeting was not reached, Biocartis convened a second
extraordinary shareholders’ meeting with the same agenda items, for
which no attendance quorum applied. During this extraordinary
general shareholders’ meeting held on 4 June 2021, the shareholders
of the Company approved all agenda items, 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 years.
FINANCIAL HIGHLIGHTS
- Product sales revenues – Total
product sales increased to EUR 40.5m in 2021, a 27% increase from
EUR 31.9m in 2020.
- Income from cartridge sales
amounted to EUR 31.6m and grew 27% year-over-year. Total cartridge
volume of 326k cartridges (+34%) included 323k commercial
cartridges (+40%) and 4k R&D cartridges (-69%). As expected,
the commercial ASP of EUR 105 in oncology was diluted by the lower
pricing of the Idylla™ SARS-CoV-2 Test, resulting in an overall
commercial ASP of EUR 96 compared to EUR 102 in 2020. Revenue
generated by sales of the Idylla™ SARS-CoV-2 products represented
14% of total revenue.
- The 331 net new installations of
the Idylla™ platform was relatively consistent with 2020 (335), but
the revenue increased by 25% to EUR 8.9m. The increase was
primarily driven by a higher ASP while the proportion of capital
sales in total placements of 51% remained comparable (2020:
49.5%).
- Total operating income – Total
operating income amounted to EUR 54.9m in 2021 compared to EUR
55.6m in 2020. In addition to grant income of EUR 2.0m, other
income included the insurance claim of EUR 4.6m for damages caused
by the fire, including the impact of lost revenue. 2020 included a
one-off settlement payment of EUR 10.3m (USD 12.0m) received in
connection with the termination of the collaboration with Genomic
Health, Inc. for the development of the Oncotype DX Breast
Recurrence Score® test on Idylla™. The continued growth of the
installed base led to a 39% increase in income from system
servicing (2021: EUR 1.7m; 2020: EUR 1.2m). Income from
collaborations decreased from EUR 10.0m in 2020 to EUR 6.1m in
2021, in the absence of licensing fees (2020: EUR 1.8m) and because
of lower R&D services provided to partners. Despite a growing
number of collaborations, the recognition of revenue is strongly
depending on and varying with the specific stage of the various
development projects.
- Cost of goods sold – Cost of goods
sold increased to EUR 33.9m, 29% higher than in 2020, driven by 40%
higher commercial cartridge volumes. Despite higher cartridge
volumes, the gross margin on product sales amounted to 16% in 2021
compared to 18% in 2020. The utilization of the high-throughput
automated manufacturing line ML2 was significantly lower than
planned as a direct result of the fire and constrained supply of
certain reagents. During the forced two-month production stop of
the ML2 line, the production of certain assays was transferred to
the ML1 line to preserve customer supply as much as possible. The
manufacturing capacity on the ML1 line is however significantly
lower and the manufacturing cost significantly higher than on the
ML2 line. However, even with low production volumes on the ML2 line
throughout 2021, the gross margin on assays produced on the ML2
line already reached 33%, clearly demonstrating the Company’s
ability to scale with unhindered and increasing production on the
ML2 line. Additionally, the gross margin also slightly decreased
because of lower pricing of the Idylla™ SARS-CoV-2 test products in
2021. Both tests are being transferred to the ML2 line in the first
half of 2022 and will generate a contribution to the absorption of
fixed manufacturing costs awaiting full capacity utilization of the
ML2 line that can produce up to 1m tests annually.
- OPEX – Total operating expenses
(excluding cost of sales) amounted to EUR 83.6m included a
write-off of EUR 3.2m on raw materials and cartridges lost in the
fire. Excluding the impact of the fire, operating expenses
increased by EUR 4.2m or 6% from EUR 76.1m in 2020. As announced at
the beginning of 2021, the Company allowed for exceptional
investment in menu expansion and diversification. The pandemic and
prioritizing the development of the Idylla™ SARS-CoV-2 Test in 2020
also led to the delay and carry-over of certain projects into
2021.
- Operational cash flow – Lower total
operating income, higher operating expenses and the outstanding
collection of most of the fire insurance claim caused the total
cash flow used in operating and investing activities to increase
from EUR 43.3m in 2020 to EUR 69.5m in 2021.
- Cash position - Biocartis’ cash
position as per 31 December 2021 amounted to EUR 53.5m and included
EUR 6.0m drawn-down on short-term credit facilities. Biocartis
intends to significantly reduce its cash burn in 2022 and is
investigating multiple options to strengthen its cash position in
the course of 2022.
- Additional details – See key
figures 2021 below for more details on the 2021 financials.
POST-PERIOD EVENTS
- Achievement 2021 key business
objectives – On 10 January 2022, Biocartis announced it had
achieved its most recent key business objectives for 2021.
- Large UK study EGFR testing – On 25
January 2022, Biocartis announced the publication of a large new
study19 comparing the difference in turnaround time between
in-house automated rapid PCR20-based EGFR analysis and
Next-Generation Sequencing (NGS) by an external laboratory, with a
focus on patient health outcome. The study concluded that a dual
PCR and NGS testing strategy for stage IV non-squamous, non-small
cell lung cancer (NSCLC) patients has the potential to improve care
and survival outcomes by providing access to the right test at the
right time.
- Partnership with Ophiomics – On 8
February 2022, Biocartis announced it had signed an agreement with
Ophiomics, a Lisbon (Portugal) based biotech company developing a
precision medicine portfolio focused on liver cancer. The
collaboration will initially focus on the commercialization of
HepatoPredict™, a prognostic gene expression signature test to help
identify which patients will benefit from curative-intent surgery,
in particular liver transplantation. 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 the Idylla™ platform.
OUTLOOK
- Commercial cartridge volume,
Idylla™ installed base and cash position outlook: see above.
- Idylla™ test menu outlook: In 2022,
Biocartis expects to launch the following assays and regulatory
milestones:
- ONCOLOGY MENU:
- Subject to further feedback from US
FDA interaction, US FDA 510(k) clearance of the Idylla™ MSI
Test
- CE-IVD launch of the Idylla™
GeneFusion Assay
- RUO launch of the Idylla™ ABC
(Advanced Breast Cancer) Assay in collaboration with LifeArc
- CE-IVD launch of the manual kit of
the Merlin Assay in collaboration with SkylineDx for
commercialization in Europe by Biocartis
- RUO launch of the ThyroidPrint© on
Idylla™ in collaboration with GeneproDx
- INFECTIOUS DISEASE PARTNER MENU:
- CE-IVD launch of the SeptiCyte®
RAPID PLUS, an assay based on SeptiCyte® RAPID that can also
distinguish between bacterial and viral infections
Key figures
2021
The tables below show an overview of the key
figures and a breakdown of operating income for 2021. A
consolidated income statement, balance sheet, cash flow statement
and statement of changes in shareholder equity of Biocartis Group
NV is presented in the paragraph ‘Financial information’ at the end
of this press release.
Key figures (EUR 1,000) |
2021 |
2020 |
% Change |
Total operating income |
54,898 |
55,559 |
-1% |
Cost of sales |
-33,922 |
-26,284 |
29% |
Research and development expenses |
-48,054 |
-45,783 |
5% |
Sales and marketing expenses |
-16,763 |
-15,736 |
7% |
General and administrative expenses |
-15,560 |
-14,618 |
6% |
Other expenses |
-3,244 |
- |
|
Operating expenses |
-117,543 |
102,421 |
15% |
Operational result |
-62,645 |
-46,862 |
34% |
Net financial result |
-8,411 |
-15,768 |
-47% |
Share in the result of associated companies |
-659 |
-532 |
24% |
Income tax |
243 |
228 |
7% |
Net result |
-71,472 |
-62,934 |
14% |
Cash flow from operating activities |
-65,716 |
-39,267 |
64% |
Cash flow from investing activities |
-3,748 |
-4,007 |
22% |
Cash flow from financing activities |
-1,204 |
-11,523 |
-90% |
Net cash flow |
-70,668 |
-54,797 |
29% |
Cash and cash equivalents1 |
53,522 |
123,668 |
-57% |
Financial debt |
154,162 |
150,558 |
2% |
1 Including EUR 1.2m of restricted cash (as a guarantee for KBC
Lease financing)
Operating income (EUR 1,000) |
2021 |
2020 |
% Change |
Collaboration revenue |
6,053 |
9,989 |
-39% |
Idylla™ system sales |
8,868 |
7,085 |
25% |
Idylla™ cartridge sales |
31,618 |
24,808 |
27% |
Product sales revenue |
40,486 |
31,893 |
27% |
Service revenue |
1,730 |
1,246 |
39% |
Total revenue |
48,269 |
43,128 |
12% |
Grants and other income |
6,629 |
12,431 |
-47% |
Total operating income |
54,898 |
55,559 |
-1% |
Product sales revenue (EUR
1,000) |
2021 |
2020 |
% Change |
Commercial revenue |
40,351 |
30,709 |
31% |
Research & development revenue |
135 |
1,184 |
-89% |
Total product sales revenue |
40,486 |
31,893 |
27% |
Income statement Total
operating income decreased by EUR 0.7m to EUR 54.9m in 2021.
Collaboration revenue amounted to EUR 6.0m, a decrease of 39% from
2020. License fees amounted to EUR 0.2m compared to EUR 1.8m in
2020, while R&D service revenue decreased by EUR 2.3m from EUR
8.2m in 2020 to EUR 5.9m in 2021.
Revenue from product sales increased with EUR
8.6m or 27% from EUR 31.9m in 2020 to EUR 40.5m in 2021. Both
Idylla™ cartridge sales and Idylla™ system revenues increased to
EUR 31.6m and EUR 8.9m, respectively (2020: EUR 24.8m and EUR
7.1m). Idylla™ cartridge sales included revenue from the sale of
323k commercial cartridges and of 4k R&D cartridges. Services
revenue amounted to EUR 1.7m in 2021 versus EUR 1.2m in 2020, a 39%
increase in line with the growing installed base of Idylla™
systems.
Grant income increased to EUR 2.0m in 2021, an
increase of EUR 0.9m compared to EUR 1.2m in 2020, and related to
the recognition of subsidies awarded in relation to the
establishment of a second cartridge manufacturing line, to the
development of the Idylla™ SARS-CoV-2 Test and the Idylla™
GeneFusion Assay (RUO), as well as the highly innovative technology
to be deployed on the Idylla™ platform aimed at enabling the
off-line customization of the Idylla™ cartridge. Other income
included a EUR 4.6m insurance claim for damages caused by the fire
on 30 July 2021. In 2020, other income included a settlement fee of
EUR 10.3m paid by Genomic Health (Exact Sciences) following the
termination of the development of the Oncotype DX Breast Recurrence
Score® test on Idylla™, and the proceeds of a USD 1.0m loan
received under the US Paycheck Protection Program (‘PPP’), that was
entirely forgiven.
Total operating expenses amounted to EUR 117.5m
in 2021, compared to EUR 102.4m in 2020. Within operating expenses,
the cost of goods sold increased by EUR 7.6m from EUR 26.3m in 2020
to EUR 33.9m in 2021 as commercial cartridge volumes increased by
40%. The resulting gross margin on product sales amounted to 16%
compared to 18% in 2020. The decrease of the gross margin resulted
from a lower ASP on the Idylla™ SARS-CoV-2 Test compared to 2020.
Prices for COVID-19 testing reduced as expected because the testing
capacity was expanded. The lower than planned utilization of the
high-throughput automated manufacturing line ML2 also caused gross
margin on cartridges to be lower than expected. Production on the
ML2 line was constrained because of the shortage of reagents during
the first half of the year and because of the forced 2-month
production stop after the fire on 30 July 2021. The production of
certain assays was transferred to the ML1 line to preserve customer
supply as much as possible, but the manufacturing capacity on the
ML1 line is significantly lower and the manufacturing cost
significantly higher than on the ML2 line.
Total operating expenses, excluding the cost of
goods sold, increased by EUR 7.5m from EUR 76.1m in 2020 to EUR
83.6m in 2021 (including EUR 3.2m inventory write-off from the
fire). R&D expenses amounted to EUR 48.1m, an increase of EUR
2.3m compared to 2020. In 2020, several projects were delayed and
carried over to 2021. Furthermore, the Company invested in further
menu expansion and diversification. These investments included the
preparatory work to apply for conformity of our CE-IVD assays under
the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
(IVDR) that establishes a new regulatory framework for in vitro
diagnostic medical devices. In addition to ongoing projects to
broaden the core oncology test menu on Idylla™ and upgrading the
functionality of the Idylla™ platform, the Company also developed
and launched its Idylla™ SARS-CoV2/Flu/RSV Panel (CE-IVD) which
detects, in one single cartridge, SARS-CoV-2, Flu A/B and RSV
nucleic acids. Finally, R&D included the continued investment
in the transfer of assays from the ML1 line to the ML2 line as well
as continuous improvement projects with a view to optimize the
manufacturing output. S&M and G&A expenses increased by EUR
1.0m and EUR 0.9m, respectively, reflecting inflation, the
restructuring of the US commercial team and increased facility
costs. Other expenses of EUR 3.2m entirely related to the write-off
of materials and finished products lost in the fire.
The operating loss for 2021 amounted to EUR
62.6m compared to EUR 46.9m in 2020. Excluding the impact of the
settlement fee of EUR 10.3m paid by Exact Sciences in 2020, the
increase of EUR 5.5m resulted from higher and exceptional
investment in various development projects and the build-out of the
commercial and organizational infrastructure.
Net financial expenses in 2021 amounted to EUR
8.4m of which EUR 8.3m related to the outstanding balance of EUR
135m on the convertible bond. In 2020, net financial expenses
amounted to EUR 15.8m, which included EUR 9.0m interest and debt
appreciation expense and a cash payment of EUR 4.3m in connection
with the incentivized exercise of conversion rights in relation to
EUR 15 million aggregate principal amount of the convertible
bonds.
Balance sheetOn 31 December
2021, total assets amounted to EUR 142.5m, compared to EUR 210.5m
at the end of 2020. Non-current assets amounted to EUR 47.4m,
compared to EUR 50.5m, mostly because of the net reduction of
intangible assets and property, plant, and equipment (EUR 3.5m) and
an impairment charge of EUR 1.4m, offset by an investment in a
convertible note issued by GeneproDx in lieu of payment for the
technology access fee due under the collaboration agreement.
Financial assets amounting to EUR 2.3m (2020: EUR 2.9m) included
the investment in the China joint venture Wondfo-Cartis, which was
adjusted by EUR 0.7m for our share in the loss for the year.
End 2021, current assets amounted to EUR 95.1m,
a decrease of EUR 64.9m from EUR 160.0m in 2020, mainly because of
the reduction in cash and cash equivalents of EUR 70.1m. Trade
receivables increased by EUR 2.7m, an increase of 20% year-on-year
which mainly resulted from the 27% increase in product revenues
compared to 2020. Inventory only increased by EUR 0.4m. Stock
levels of finished cartridges and raw materials decreased as a
result of the fire and the insufficient supply of reagents to
deliver all open customer orders. On the other hand, the inventory
of Idylla™ instruments increased awaiting the availability of
sufficient cartridges to onboard new customers. Other receivables
increased by EUR 2.7m from EUR 4.0m in 2020 to EUR 6.6m in 2021 and
included EUR 3.8m of uncollected insurance claims for fire damages.
Other current assets decreased by EUR 0.4m.On 31 December 2021,
total financial debt amounted to EUR 154.2 compared to EUR 150.6m
end of 2020. The increase resulted from the appreciation of the
convertible bond by EUR 2.9m and a EUR 6.0m draw-down on working
capital facilities, offset by the scheduled repayment of leasing
obligations of EUR 5.2m. Trade payables decreased by EUR 2.3m to
EUR 11.6m in 2021. Other current liabilities increased by EUR 0.9m
to EUR 8.4m, partly related to VAT payable as a result of Brexit
and increased payroll related provisions as the number of employees
(FTE or Full Time Equivalent) increased from 366 in 2020 to 407 in
2021.
Cash flow statement The cash
flow from operating activities in 2021 increased by EUR 26.4m to
EUR 65.7m compared to EUR 39.3m in 2020. Apart from the collection
of the EUR 10.3m settlement fee paid by Exact Sciences, 2020 was
characterized by more cautious spending because of the pandemic and
several projects being carried over to 2021, causing the operating
loss to increase by EUR 15.8m to EUR 62.6m in 2021. Investments in
working capital amounted to EUR 9.6m, a year-on-year increase of
EUR 13m, in line with the expansion of our commercial activity and
a significantly higher amount of trade payables at the end of last
year. Furthermore, EUR 3.8m of losses caused by the fire were not
yet collected from the insurance carriers on 31 December 2021.
Interest expense was EUR 0.9m lower than in 2020 following the
decrease of the convertible bond by EUR 15.0m in 2020. The cash
flow from investing activities in 2021 amounted to EUR -3.7m,
compared to EUR -4.0m in 2020. Investments in property, plant and
equipment amounted to EUR 3.7m in 2021, an increase of EUR 0.7m
compared to 2020 and including capitalized Idylla™ systems as well
as investments in laboratory and manufacturing equipment. The cash
flow from financing amounted to EUR -1.2m as a result of the
scheduled repayment of lease and other obligations offset by the
drawdown of EUR 6.0m on existing working capital facilities.
The total cash flow for 2021 amounted to EUR
70.7m compared to EUR -54.8m in 2020.
Financial calendar 2022
- 31 March
2022 Publication
2021 annual report
- To be determined
Q1 2022 Business Update
- 13 May 2022
AGM Biocartis Group
NV
- 1 September 2022
H1 2022 results
- To be determined
Q3 2022 Business Update
Financial information
The consolidated financial statements have been
prepared in accordance with IFRS, as adopted by the EU. The
financial information included in this press release is an extract
from the full IFRS consolidated financial statements, which will be
published on 31 March 2022. The financial information in this press
release was not audited by the statutory auditor.
Consolidated
income
statement
|
Years ended 31 December |
In EUR 000 |
2021 |
|
2020 |
|
|
|
|
Revenue |
|
|
|
Collaboration revenue |
6,053 |
|
9,989 |
Product sales revenue |
40,486 |
|
31,893 |
Service revenue |
1,730 |
|
1,246 |
|
48,269 |
|
43,128 |
Other operating income |
|
|
|
Grants and other income |
6,629 |
|
12,431 |
|
|
|
|
Total operating income |
54,898 |
|
55,559 |
|
|
|
|
Operating expenses |
|
|
|
Cost of sales |
-33,922 |
|
-26,284 |
Research and development expenses |
-48,054 |
|
-45,783 |
Sales and marketing expenses |
-16,763 |
|
-15,736 |
General and administrative expenses |
-15,560 |
|
-14,618 |
Other expenses |
-3,244 |
|
|
|
-117,543 |
|
-102,421 |
|
|
|
|
Operating loss for the year |
-62,645 |
|
-46,862 |
|
|
|
|
Financial expense |
-9,488 |
|
-14,569 |
Other financial results |
1,077 |
|
-1,199 |
Financial result, net |
-8,411 |
|
-15,768 |
|
|
|
|
Share in the results of associates |
-659 |
|
-532 |
|
|
|
|
Loss for the year before taxes |
-71,715 |
|
-63,162 |
Income taxes |
243 |
|
228 |
Loss for the year after taxes |
-71,472 |
|
-62,934 |
|
|
|
|
Attributable to owners of the Company |
-71,472 |
|
-62,934 |
Attributable to non-controlling interest |
|
|
|
|
|
|
|
Earnings per share |
|
|
|
Basic and diluted loss per share |
-1.26 |
|
-1.11 |
Consolidated
balance
sheet
|
|
As of 31 December, |
|
|
In EUR 000 |
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
|
|
Intangible assets |
5,067 |
|
5,645 |
|
|
|
Property plant and equipment |
37,192 |
|
40,098 |
|
|
|
Financial assets |
1,140 |
|
0 |
|
|
|
Investment joint ventures |
2,344 |
|
2,893 |
|
|
|
Other non-current receivables |
16 |
|
426 |
|
|
|
Deferred tax assets |
1,595 |
|
1,472 |
|
|
|
|
47,354 |
|
50,534 |
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Inventories |
16,106 |
|
15,712 |
|
|
|
Trade receivables |
16,206 |
|
13,488 |
|
|
|
Other receivables |
6,556 |
|
3,960 |
|
|
|
Other current assets |
2,736 |
|
3,155 |
|
|
|
Cash and cash equivalents* |
53,522 |
|
123,668 |
|
|
|
|
95,126 |
|
159,983 |
|
|
|
|
|
|
|
|
|
|
Total assets |
142,480 |
|
210,517 |
|
|
|
|
|
|
|
|
|
Equity and liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital and reserves |
|
|
|
|
|
|
Share capital |
-220,657 |
|
-220,657 |
|
|
|
Share premium |
711,874 |
|
711,874 |
|
|
|
Share based payment reserve |
6,862 |
|
6,102 |
|
|
|
Accumulated deficit |
-526,405 |
|
-455,343 |
|
|
|
Other comprehensive income |
-5,571 |
|
-5,152 |
|
|
|
Total equity attributable to owners of the
Company |
-33,897 |
|
36,824 |
|
|
|
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
|
Provisions |
75 |
|
0 |
|
|
|
Borrowings and lease liabilities |
14,133 |
|
18,625 |
|
|
|
Convertible debt |
128,151 |
|
125,260 |
|
|
|
Deferred income |
313 |
|
363 |
|
|
|
|
142,672 |
|
144,248 |
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Borrowings and lease liabilities |
11,878 |
|
6,673 |
|
|
|
Trade payables |
11,560 |
|
13,907 |
|
|
|
Deferred income |
1,822 |
|
1,278 |
|
|
|
Other current liabilities |
8,445 |
|
7,587 |
|
|
|
|
33,705 |
|
29,445 |
|
|
|
|
|
|
|
|
|
Total equity and liabilities |
142,480 |
|
268,323 |
|
|
* Cash and cash equivalents for 31 December 2020
and 2021 include EUR 1.2 million restricted cash related to KBC
Lease financing |
Consolidated cash flow statement
|
Years ended 31 December |
In EUR 000 |
2021 |
|
2020 |
Operating activities |
|
|
|
|
|
|
|
Loss for the year |
-71,472 |
|
-62,934 |
|
|
|
|
Adjustments for |
|
|
|
Depreciation and amortization |
9,845 |
|
9,748 |
Impairment losses |
1,362 |
|
1,698 |
Income taxes in profit and loss |
-243 |
|
-228 |
Financial result, net |
8,411 |
|
15,768 |
Unrealized exchange gains/ losses |
1,134 |
|
-1,030 |
Net movement in defined benefit obligation |
69 |
|
-323 |
Share of net profit of associate and a joint venture |
659 |
|
532 |
Share based payment expense |
760 |
|
1,432 |
Other |
-162 |
|
-80 |
|
|
|
|
Changes in working capital |
|
|
|
Net movement in inventories |
-2,737 |
|
-4,042 |
Net movement in trade and other receivables and other current
assets |
-5,916 |
|
1,449 |
Net movement in trade payables & other current liabilities |
-1,489 |
|
6,333 |
Net movement in deferred income |
494 |
|
-415 |
|
-59,285 |
|
-32,092 |
|
|
|
|
Interests paid |
-6,429 |
|
-7,172 |
Taxes paid |
-2 |
|
-3 |
Cash flow used in operating activities |
-65,716 |
|
-39,267 |
|
|
|
|
Investing activities |
|
|
|
Interests received |
7 |
|
13 |
Acquisition of property, plant & equipment |
-3,686 |
|
-3,005 |
Acquisition of intangible assets |
-69 |
|
-15 |
Acquisition of investment in a joint venture |
0 |
|
-1,000 |
Investment convertible note |
|
|
|
Cash flow used in investing activities |
-3,748 |
|
-4,007 |
|
|
|
|
Financing activities |
|
|
|
Proceeds from borrowings |
6,000 |
|
0 |
Convertible bond – incentivized conversion |
0 |
|
-4,306 |
Net proceeds from the issue of common shares, net of transaction
costs |
0 |
|
0 |
Repayment of borrowings |
-7,089 |
|
-7,167 |
Bank charges |
-115 |
|
-50 |
Cash flow from financing activities |
-1,204 |
|
-11,523 |
|
|
|
|
Net increase / (decrease) in cash and cash
equivalents |
-70,668 |
|
-54,797 |
|
|
|
|
Cash and cash equivalents at the beginning of the year |
123,668 |
|
178,725 |
Effects of exchange rate changes on the balance of cash held in
foreign currencies |
522 |
|
-260 |
Cash and cash equivalents at the end of the
year* |
53,522 |
|
123,668 |
* Including EUR 1,2m restricted cash related to KBC Lease
financing
Consolidated
statement of
changes in
shareholder
equity
|
|
|
Attributable to owners of the Group |
|
|
In EUR 000 |
|
|
Share capital |
|
Share premium |
|
Share based payment reserve |
|
Other comprehensive income |
|
Accumulated deficit |
|
Total equity attributable to the owners of the
Group |
|
Total equity |
Balance as at 1 January
2020 |
|
|
-220,668 |
|
698,027 |
|
4,670 |
|
-5,291 |
|
-392,259 |
|
84,480 |
|
84,480 |
Loss for the period |
|
|
|
|
|
|
|
|
|
|
-62,934 |
|
-62,934 |
|
-62,934 |
Re-measurement gains and losses on defined benefit plan |
|
|
|
|
|
|
|
|
139 |
|
|
|
139 |
|
139 |
Consolidation translation difference |
|
|
|
|
|
|
|
|
|
|
-150 |
|
-150 |
|
-150 |
Total comprehensive income |
|
|
|
|
|
|
|
|
139 |
|
-63,084 |
|
-62,945 |
|
-62,945 |
Share-based payment expense |
|
|
|
|
|
|
1,432 |
|
|
|
|
|
1,432 |
|
1,432 |
Convertible bond - incentivized conversion |
|
|
11 |
|
13,847 |
|
|
|
|
|
|
|
13,857 |
|
13,857 |
Other |
|
|
|
|
|
|
|
|
|
|
|
|
0 |
|
0 |
Balance as at 31 December
2020 |
|
|
-220,657 |
|
711,875 |
|
6,102 |
|
-5,152 |
|
-455,343 |
|
36,824 |
|
36,824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as at 1 January
2021 |
|
|
-220,657 |
|
711,875 |
|
6,102 |
|
-5,152 |
|
-455,343 |
|
36,824 |
|
36,824 |
Loss for the period |
|
|
|
|
|
|
|
|
|
|
-71,472 |
|
-71,472 |
|
-71,472 |
Re-measurement gains and losses on defined benefit plan |
|
|
|
|
|
|
|
|
-419 |
|
|
|
-419 |
|
-419 |
Consolidation translation difference |
|
|
|
|
|
|
|
|
|
|
410 |
|
410 |
|
410 |
Total comprehensive income |
|
|
|
|
|
|
|
|
-419 |
|
-71,062 |
|
-71,481 |
|
-71,481 |
Share-based payment expense |
|
|
|
|
|
|
760 |
|
|
|
|
|
|
|
|
Convertible bond - incentivized conversion |
|
|
|
|
|
|
|
|
|
|
|
|
760 |
|
760 |
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as at 31 December
2021 |
|
|
-220,657 |
|
711,875 |
|
6,102 |
|
-5,571 |
|
-526,405 |
|
-33,897 |
|
-33,897 |
--- END ---
More information: Renate
DegraveHead of Corporate Communications & Investor Relations
Biocartise-mail rdegrave@biocartis.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.
Forward-looking
statementsCertain 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,
China and Japan
2 In the US, distribution of the Idylla™
SARS-CoV-2 Test was initiated in Q3 2020 per US FDA Policy for
Coronavirus Disease-2019 Tests During the Public Health Emergency
(Revised), May 2020, Section IV.C. Commercial Manufacturer
Development and Distribution of Diagnostic Tests Prior to EUA
Submission3 Research Use Only, not for use in diagnostic
procedures4 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 4 January 20225 For use as an in vitro diagnostic
device intended for the identification of microsatellite
instability (MSI) status in colorectal (colon) cancer (CRC) to aid
in the differentiation between sporadic CRC and potential Lynch
syndrome6 Respiratory Syncytial Virus7 SeptiCyte® RAPID is
developed by Immunexpress Inc in collaboration with Biocartis.
Biocartis has the exclusive distribution rights for the EU. The
test is not available in all countries. Availability to be checked
with a local Biocartis representative8 The Idylla™ Instrument and
Idylla™ Console have been exempted by the US FDA since 12 July 2017
and as such are not subject to 510(k) notification requirements
prior to being placed on the US market for in vitro diagnostic use
with US FDA approved or cleared assays9 Immunexpress Pty Ltd
(‘Immunexpress’) is a Seattle-based molecular diagnostic company
focused on improving outcomes for suspected sepsis patients10 China
NMPA requires local type testing for the market approval
of Class II and Class III medical
device/IVD products. China local type
testing is a mandatory step for registration and must be
completed before the initiation of local clinical studies if
needed. Testing was conducted by a testing lab authorized by the
NMPA11 Replacing the current Directive 98/79/EC on in vitro
diagnostic medical devices from 26 May 202212 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
13 The Idylla™ Instrument and Idylla™ Console
have been exempted by the US FDA since 12 July 2017 and as such are
not subject to 510(k) notification requirements prior to being
placed on the US market for in vitro diagnostic use with US FDA
approved or cleared assays14 Host-response based tests focus on
measuring biomarkers that are indicative of the response of a
patient’s immune system to an infection rather than measuring
pathogens that are the cause of the infection15 EGFR or ‘Epidermal
growth factor receptor’ mutations are the second most common
oncogenic driver in non-small cell lung cancer (NSCLC)16 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.2020.11.00917 Which can be useful
in cases where EGFR mutation results were negative and further
testing is needed18 Petiteau, C.; Robinet-Zimmermann, G.; Riot, A.;
Dorbeau,M.; Richard, N.; Blanc-Fournier, C.; Bibeau, F.; Deshayes,
S.; Bergot, E.; Gervais, R.; et al. Contribution of the Idylla™
System to Improving the Therapeutic Care of Patients with NSCLC
through Early Screening of EGFR Mutations. Curr. Oncol. 2021, 28,
4432–4445. https://doi.org/10.3390/curroncol28060376, published 3
November 202119 A. Finall et al., J Clin Pathol . 2022 Jan
18;jclinpath-2021-207987. doi: 10.1136/jclinpath-2021-207987.
Online ahead of print20 Polymerase Chain Reaction or PCR is a fast
and inexpensive technique used to amplify or copy small segments of
DNA and used to detect genetic material such as biomarkers that
drive cancer
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