Press release Biocartis Group NV: Second Update on Fire Incident at Biocartis Warehouse
17 August 2021 - 7:00AM
Press release Biocartis Group NV: Second Update on Fire Incident at
Biocartis Warehouse
PRESS RELEASE: 17 August 2021, 07:00 CESTREGULATED
INFORMATION – INSIDE INFORMATION
Second Update
on Fire Incident at
Biocartis
Warehouse
Mechelen,
Belgium, 17 August
2021 – Biocartis Group NV (the
‘Company’ or ‘Biocartis’) (Euronext Brussels: BCART) provides a
second update regarding the impact on its production and 2021
Idylla™ commercial cartridge growth outlook, following a fire at
one of the Company’s warehouse facilities in Mechelen, Belgium,
during the night of 30 July 2021.
Update on production
impactA first update was issued on 2 August 2021,
stating that the manufacturing equipment of the high-throughput
‘ML2’ cartridge production line located in the area adjacent to the
affected warehouse was not damaged, but production at the ML2 line
was temporarily suspended due to the need for structural repairs to
the building and select supporting systems. Those repairs have
already been initiated and are due to be completed by the second
half of September 2021. As previously communicated, the stock of
Idylla™ instruments and consoles was not impacted. About half of
the Company’s stock of finished Idylla™ cartridge products was
still available to meet short term demand across most of the
product portfolio. In terms of raw materials, the stock of plastic
parts is unaffected, but a significant part of the stock of
reagents used as raw materials in Idylla™ cartridge manufacturing
was lost in the fire. Raw materials are available to continue
cartridge manufacturing on the ML1 production line and orders have
been placed to replenish critical reagents from different suppliers
to minimize production delays.
Additional personnel and resources have
temporarily been redirected to the ML1 line to increase production
on this line, which was not affected by the fire. The Company is
however running at considerably lower manufacturing capacity until
production on the ML2 line is resumed, which is expected by the
second half of September 2021, subject to critical reagents being
supplied in sufficient quantities by then. The pandemic caused a
global shortage of reagents and lead times for certain reagent
supplies may be longer than usual, but the Company is working
closely with its suppliers to minimize the impact. The Company is
also collaborating with its customers and partners to serve their
needs within the current capacity constraints, which the Company
confirms to be temporary.
Impact of the
fire on the 2021
outlookThis incident occurred at
a time when the Company was gearing up manufacturing capacity to
meet the strong growth in demand for its products seen in the first
half of the year. Biocartis installed 189 new Idylla™ instruments
in H1 2021 and almost doubled the cartridge volume year-over-year
with 156k Idylla™ cartridges sold (+96%). Although Q2 2020 volumes
were significantly impacted by the pandemic, the H1 2021 growth in
oncology testing was strong and infectious diseases testing volumes
remained robust at levels comparable to H2 2020 volumes. Based on
the commercial demand for the remainder of the year, as projected
prior to the fire incident, the Company would have been in a
position to confirm its earlier guidance of commercial cartridge
growth of 40%-60%, with the high-end of the range depending on
strong demand for the new Idylla™ SARS-CoV-2 Panel1 during the
upcoming flu season.
At this point in time however, the potential
impact of the fire on the commercial cartridge volumes for H2 2021
cannot yet be reasonably estimated. Timely availability of reagents
cannot yet be confirmed by suppliers. Also, with the constrained
production capacity on the ML1 line, the Company has taken the
decision to prioritize manufacturing of oncology tests and allocate
a dedicated manufacturing capacity to partner projects. This may
compromise SARS-CoV-2 testing volumes and the planned upcoming
launch of the Idylla™ SARS-CoV-2 Panel. The Company will provide an
update on 2 September 2021 in its H1 2021 results release.
The Company has in place customary insurance coverage, also
covering business continuity, and does not expect any negative
impact on its liquidity.
--- END ---
More information: Renate
DegraveHead of Corporate Communications and Investor Relations
Biocartise-mail rdegrave@biocartis.com
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 SARS-CoV-2 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. 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. Please refer to the product labeling for applicable
intended uses for each individual Biocartis product. 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 Building upon the success of its Idylla™
SARS-CoV-2 Test (CE-IVD), the new Idylla™ SARS-CoV-2 Panel is
expected to be launched as a CE-IVD and is expected to detect, in
one single cartridge, SARS-CoV-2, Flu A/B and RSV (Respiratory
Syncytial Virus) nucleic acids, with results in approx. 90
minutes
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