Biocartis Group NV: Biocartis announces 2016 results, 2017 outlook and change in CEO position
(Thomson Reuters ONE) -
PRESS RELEASE: REGULATED - INSIDE INFORMATION
Thursday, 2 March 2017, 07:01 CET
BIOCARTIS ANNOUNCES 2016 RESULTS, 2017 OUTLOOK AND CHANGE IN CEO POSITION
Mechelen, Belgium, 2 March 2017 - Biocartis Group NV (the 'Company' or
'Biocartis'), an innovative molecular diagnostics company (Euronext Brussels:
BCART), today announces its operational highlights and financial results for
2016, prepared in accordance with IFRS as adopted by the European Union.
Furthermore, the Company today provides its outlook for 2017 and announces a
change in the Company's CEO position.
Overview of key messages
2016 results
* Installed base: Installed base Idylla(TM) instruments more than doubled in
2016 by adding a total of 224 instruments. Total installed base year end was
close to 390 instruments.
* Cartridge consumption: Commercial cartridge volume in 2016 increased to over
25,000 cartridges which represents approx. 7.5 times the total commercial
volume of 2015.
* Test menu: On market oncology menu expanded to 7 tests.
* Revenues: Total 2016 operating income amounted to EUR 13.8m. Product
revenues in 2016 amounted to EUR 6.8m, representing an increase of 88%
compared to 2015.
* Cash position: Cash and cash equivalents on 31 December 2016 amounted to EUR
83.2m.
Guidance 2017
* Installed base: 640 Idylla(TM) instruments by the end of 2017, based on
250-275 new instrument placements.
* Cartridge consumption: commercial cartridge volume in 2017 to be at least
three times 2016 volume.
* Cash position: Around EUR 40m by 2017 year end.
Change in CEO position
Rudi Pauwels has expressed his preference to focus on the longer term strategy
of the Company, including a pathway towards a Next-Generation Sequencing based
product offering. Therefore, the Board has decided that Rudi Pauwels will take
on the role of Chairman of a new Strategy Committee of the Board and that he
will pass on the role of CEO to a successor. The Company is confident that a
successor can be announced in the next few months. Hilde Windels, currently
Deputy CEO, will assume the role of CEO until a successor is on board.
Biocartis will host a conference call with live webcast presentation today at
14:00 CET / 13:00 BST (UK) / 08:00 EDT (US) to discuss the 2016 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(0)20 3427 1901 (standard international),
followed by the confirmation code 9539312.
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
* Installed base - A total of 224 Idylla(TM) instruments were added to the
installed base in 2016, resulting in a total installed base of close to 390
instruments per year end 2016. This compared to an installed base of 165
instruments at the beginning of 2016 and the latest 2016 guidance of adding
at least 175 instruments. The three key drivers behind the installed base
growth in 2016 were menu expansion, an increased awareness by end customers
on the excellent performance of the Idylla(TM) technology (as demonstrated
in recent published comparative studies[1]) and the growing interest from
pharmaceutical companies. The growth in installed base end of 2016 was also
driven by the regulatory upgrade, i.e. the CE-marking of the Idylla(TM)
NRAS-BRAF Mutation Test.
* Cartridge consumption - In line with the installed base growth and menu
expansion, commercial Idylla(TM) cartridge consumption in 2016 was over
25,000 cartridges, which is approx. 7.5 times the total commercial cartridge
volume of 2015.
* Amgen collaboration - On 3 February 2016, Biocartis announced a
collaboration with Amgen to evaluate Idylla(TM) RAS testing as a tool for
rapid decentralized testing in a range of countries[2]. This collaboration
was expanded in December 2016 to include up to 10 new European countries and
will enable several dozen additional selected hospitals to accelerate
patient access to RAS biomarker information using Biocartis' Idylla(TM)
platform and RAS tests.
* Commercial footprint - During 2016, Biocartis further executed the expansion
of its global commercial footprint by obtaining new market authorizations
for 8 additional geographies and signing 9 new distribution agreements. More
specifically, on 17 November 2016, Biocartis announced its partnership with
Thermo Fisher Scientific Inc. to distribute in the US its Idylla(TM)
platform and accompanying assays, with a first focus on oncology products.
Both parties expect to start commercial roll-out in the US as of H2 2017.
Biocartis has retained the option to sell both its Idylla(TM) platform and
assays via direct sales channels into the US market.
Idylla(TM) test menu highlights
* Colorectal cancer menu - During 2016, Biocartis significantly expanded and
strengthened its colorectal cancer menu by:
* Completing its offering of metastatic colorectal cancer (mCRC) tests for
clinical use on the Idylla(TM) platform with the CE-marking of its solid
biopsy Idylla(TM) NRAS-BRAF Mutation Test on 15 December 2016.
Biocartis' mCRC offering follows the most recent clinical guidelines and
opens routes towards faster treatment selection.
* Entering into a collaboration with Merck KGaA (Merck) for the
development and commercialization of a new liquid biopsy RAS biomarker
test for patients with mCRC that was announced on 7 January 2016. This
comprises two Idylla(TM) assays of which the first one, the Idylla(TM)
ctKRAS Mutation Assay was launched in December 2016 under a Research Use
Only (RUO) label and is Biocartis' second liquid biopsy test. The second
assay under the agreement, the Idylla(TM) ctNRAS-BRAF-EGFR492 Mutation
Assay (RUO) was launched on 2 March 2017. Biocartis and Merck plan to
implement the Idylla(TM) liquid biopsy RAS test in numerous medical
centers across the world[3] following CE-marking of both tests, expected
in H2 2017.
* Signing an exclusive licensing of a recently detected set of ectodomain
mutations in the Epidermal Growth Factor Receptor (EGFR)[4] that convey
resistance to certain anti-EGFR therapies in colorectal cancer from Dr.
Montagut (Hospital del Mar, Barcelona, Spain), Dr. Bardelli and Dr.
Arena (University of Torino, Italy), entered into on March 2016. The aim
is to integrate these novel biomarkers (which complement the EGFR S492R
marker licensed by Biocartis in 2013) into molecular diagnostic tests
for the Idylla(TM) platform, to enable physicians to monitor therapy
resistance in patients and thereby allowing for optimizations of
treatment regimes.
* Lung cancer menu - On 21 June 2016, Biocartis launched the first test of its
lung cancer menu with the Idylla(TM) EGFR Mutation Assay (RUO). This
advanced, fully automated molecular test is designed to detect over 50 EGFR
mutations which commonly occur in lung cancer on the basis of only a single
slice of tumor[5] tissue. Its extreme ease-of-use allows for testing
irrespective of location or laboratory expertise level and, as such, this
assay has the potential to enable more wide-spread testing of lung cancer
specimens.
* Performance studies - During 2016, a total of eight different promising
publications[6] were issued on the performance of Idylla(TM) oncology tests,
four of them were presented at the renowned international oncology
conferences ASCO and ESMO. This included a comparative study[7] organized by
AstraZeneca, a global biopharmaceutical company, where 12 different KRAS
mutation detecting technologies, including Next-Generation Sequencing (NGS)
and quantitative Polymerase Chain Reaction (PCR), were compared for the
detection of KRAS mutations, using blinded samples. This study confirmed the
best-in-class status of the Idylla(TM) KRAS technology.
* US FDA achievements - Two important achievements were realized with the US
Food and Drug Administration (FDA) in 2016:
* On 1 June 2016, Biocartis received Emergency Use Authorization by the US
FDA for the Idylla(TM) Ebola Virus Triage Test (Idylla(TM) EBOV Test)
that runs on the Idylla(TM) platform. This test was co-developed by
Biocartis, Janssen Diagnostics (a division of Janssen Pharmaceutica NV)
and the Belgian Institute of Tropical Medicine.
* On 22 December 2016, Biocartis completed the 510(k) submission[8] to the
US FDA of its Idylla(TM) platform, comprising of the Idylla(TM)
Instrument and the Idylla(TM) Console. This submission was done in
parallel with the 510(k) submission by Biocartis' strategic partner
Janssen Diagnostics of the Janssen Idylla(TM) Respiratory (IFV-RSV)
Panel Test.
Operational highlights
* Strengthening management team - Hilde Eylenbosch, who joined Biocartis'
Board of Directors in May 2016, took over the position of Chief Commercial
Officer as of 17 November 2016. Ulrik Cordes (the Company's previous Chief
Commercial Officer since September 2013) transitioned on that date into the
function of EVP Pharma Collaborations and Companion Diagnostics, aimed at
building a strong complementary and companion diagnostic business.
Furthermore, during Q1 2016, Biocartis strengthened its manufacturing
expertise with the appointment of Reginald Van Genechten as Head of
Manufacturing and Supply Chain.
* Cartridge manufacturing - During 2016, Biocartis together with its partners
continued the works on a second cartridge manufacturing line. The aim is to
have this line operational by the end of 2017. It should provide for an
additional annual cartridge capacity of over 1 million Idylla(TM)
cartridges.
Financial highlights
* Product sales revenues - Total product sales revenues in 2016 increased with
approx. 88% to EUR 6.8m from EUR 3.6m in 2015. This increase was
predominantly driven by cartridge sales that amounted to EUR 4.0m in 2016,
representing over 3 times the 2015 cartridge sales of EUR 1.3m. System sales
increased with approx. 20% from EUR 2.3m in 2015 to EUR 2.8m in 2016.
* Equity raise - On 17 November 2016, Biocartis successfully raised EUR 32.7m
of gross proceeds by means of a private placement via an accelerated
bookbuild offering of 4,058,917 new shares (being approximately 10% of the
Company's outstanding shares) at an issue price of EUR 8.05 per share.
* Debt financing - On 20 July 2016, Biocartis announced it had attracted EUR
55m of non-dilutive financing consisting of a EUR 40m bank and lease
financing facility as well as a new subordinated loan of EUR 15m. The bank
and lease financing facility consists of EUR 15m lease financing and EUR
25m multiple purpose credit lines (the credit lines are partially guaranteed
by the Flemish Government). Biocartis' total debt outstanding amounted to
EUR 31.4m as per 31 December 2016, compared to EUR 10.8m as per 31 December
2015.
* Cash flow - Biocartis' cash flow from operational and investment activities
amounted to EUR -62.7m in 2016, compared to EUR -32.8m in 2015, mainly
driven by increased operational expenses and higher investments for
cartridge manufacturing expansion. Given a cash flow from financing
activities in 2016 of EUR 41.8m, the total net cash flow of 2016 amounted to
EUR -20.9m.
* Cash position - Biocartis' cash position as per 31 December 2016 amounted to
EUR 83.2m compared to EUR 104.1m as per 31 December 2015.
* Additional details - see 'key figures for 2016' below for more details on
the 2016 financials.
Commenting on the 2016 results, Rudi Pauwels, Chief Executive Officer of
Biocartis, said: "Our 2016 performance and the continued feedback from our
customers and their patients confirms our belief that with Idylla(TM) we can
disrupt the global market of molecular diagnostics. We continue to see an
increased interest by large pharmaceutical companies for easy and rapid
molecular diagnostics testing needed for their high precision treatments, and to
keep the healthcare model sustainable. We already saw this translated into
valuable new long-term partnerships for Biocartis. Continued innovation around
cancer treatments, such as liquid biopsy based monitoring, also indicates that
the market for our current and future products is larger than initially thought.
Still a lot of work is needed to materialize our ambitions. Starting
commercialization in the US in 2017 is an important next step here. This not
only because of the size of this market, but also due to the US' current
centralized nature of MDx testing which will allow our clients to optimally
benefit from the USPs Idylla(TM) has to offer. 2017 is definitely going to be
another exciting year for Biocartis!"
Post-period events
* Companion diagnostics (CDx) - In January 2017, Biocartis signed a first
companion diagnostics partnership with an undisclosed pharmaceutical company
(ranked amongst the global top 10 pharmaceutical companies by sales) for the
joint development of an Idylla(TM) CDx test for an undisclosed phase II
oncology compound.
* Change CEO position - Today, on 2 March 2017, Biocartis announced a change
in the CEO position of the Company.
* Launch of the Idylla(TM) ctNRAS-BRAF-EGFR S492R Mutation Test - On 2 March
2017, Biocartis launched the Idylla(TM) ctNRAS-BRAF-EGFR S492R Mutation
Assay (Research Use Only[9]), an important milestone the partnership with
Merck[10] as well as the Company's third liquid biopsy test for oncology.
Outlook 2017
* Target of growing the total installed base to 640 Idylla(TM) instruments by
adding 250-275 new instrument placements, driven by the ongoing menu and
geographical expansion.
* Annual commercial cartridge consumption in 2017 is targeted to grow to over
three times the 2016 volume.
* 510(k) approval from the US FDA is expected for the Idylla(TM) Instrument,
the Idylla(TM) Console and the Idylla(TM) Respiratory (IFV-RSV) Panel Test.
* Menu expansion is aimed at further completing Biocartis' core oncology menu
in the course of 2017:
* CE-marking Idylla(TM) EGFR Mutation Test (Q2 2017);
* CE-marking Idylla(TM) NRAS Mutation Test (Q2/Q3 2017): this test will
give more flexibility to customers and will allow for price
differentiation with the Idylla(TM) NRAS-BRAF Mutation Test in
geographies where BRAF testing for mCRC patients is not reimbursed;
* CE-marking Idylla(TM) ctKRAS Mutation Test and Idylla(TM) ctNRAS-BRAF
Mutation Test as part of the partnership with Merck (H2 2017); and
* Launch of a liquid biopsy version of the Idylla(TM) EGFR Mutation Assay
(RUO, H2 2017). Note: this product will be initially launched on the
basis of a manual DNA extraction protocol anticipating a fully automated
ctEGFR Mutation Assay that is also under development.
* Biocartis targets a cash position by the end of 2017 of around EUR 40m.
Update test menu strategy
Biocartis continuously monitors market, technological and scientific
developments that have an impact on the competitive positioning of its current
and future menu of Idylla(TM) tests. These reviews have resulted in a menu
optimization as summarized below:
* Biocartis is observing a stronger than expected traction of the Idylla(TM)
platform in oncology. This traction is primarily fueled by Biocartis' unique
position in providing FFPE[11]-based sample-to-result solutions, strong
performance data of Idylla(TM) tests, and Biocartis' potential to benefit
from the promises of liquid biopsy testing, immuno-oncology therapies and
Next-Generation Sequencing (NGS). This has led to increased interest from
customers and pharmaceutical companies. Therefore, the Company has decided
to increase its focus on oncology and to turn this positive momentum into
solid market share and revenue growth which:
* From a menu perspective, should result in a faster and broader expansion
of the Company's oncology offering into comprehensive menus for
colorectal, lung, breast, urology and related tumors from a biomarker
point of view, as well as expansion into immunotherapy and DNA repair
fields[12]. This is facilitated by capturing the potential of oncology
test development with collaboration partners, including CDx
partnerships; and
* From a commercialization perspective, entails entering into additional
commercial and regulatory collaborations with pharmaceutical and biotech
companies to further accelerate worldwide market adoption of Idylla(TM).
* Idylla(TM) is designed to be extremely versatile and therefore the
Company remains committed to valorize the potential of the platform in
other areas. This especially holds true for infectious diseases given
the unique position Idylla(TM) has within the field of syndromic panels
and bloodstream infections (including sepsis). Both areas will remain
the focus of Biocartis within this market. However, going forward the
Company's infectious disease strategy could include more partnership
elements.
Additional background on the summarized menu update will be provided during
today's webcast presentation at 14:00 CET.
Change in CEO position
After having fulfilled the CEO position for 10 years, Founder Rudi Pauwels has
expressed his preference to the Board to focus on the longer term strategy of
the Company, including a pathway towards a Next-Generation Sequencing based
product offering. The board has decided that Rudi will take on the role of
Chairman of a new Strategy Committee of the Board and that Hilde Windels will
assume the role of CEO until a successor for Rudi Pauwels is on board. Since the
appointment of Hilde Windels as Deputy CEO in 2015, Rudi Pauwels was already
more focused on the strategy and vision of Biocartis, whereas the day to day
execution was delegated to Hilde Windels. The Company is confident that a
successor can be announced in the next few months.
Rudi Pauwels, Founder of Biocartis, commented: "Ten years ago, we embarked on a
journey to develop high precision molecular diagnostic solutions that by design
would be more accessible to laboratories and healthcare settings around the
globe. I had the pleasure to work intensely together with a great team on the
development of the Idylla(TM) platform that has its roots at Philips. The CE-
marking late 2014 was the beginning of the commercial phase and, fueled by a
growing number of tests, the Idylla(TM) solution is now increasingly finding its
way to customers in Europe and around the world. I am particularly pleased to
see that the hard work during the development has translated into great
performance of our first tests. Building further on these foundations, Biocartis
must now increasingly focus on worldwide commercial expansion and on the pathway
towards building significant top line revenue. I therefore feel it is time for
me to hand over the torch as CEO and I am happy that Hilde Windels, with whom I
have been working side-by-side over the last 6 years, is taking over from me as
interim CEO. This will allow me to increase my focus on innovation and strategy
even more, in another capacity. I look forward to continue to be involved with
Biocartis and to assist the Company in its roll-out of innovative products and
breakthrough solutions that I believe can make a significant contribution to the
growing role of molecular diagnostics in healthcare."
Rudi Mariën, Chairman of Biocartis, added: "We are thankful for Rudi's
dedication to Biocartis over the past years. Without him, Biocartis would not
have been what it is today. Under his leadership, the Company launched its
flagship program Idylla(TM), successfully raised EUR 115m in its IPO and
established promising partnerships with healthcare leaders including amongst
others Johnson and Johnson, Abbott, Amgen, Merck and Thermo Fisher Scientific.
We are pleased to see that Rudi will remain active on the Board, which will
enable Biocartis to continue to benefit from his visionary views and insights on
how to continue to deliver on our promises while remaining at the forefront of
innovation."
Key figures for 2016
The tables below show an overview of the key figures and a breakdown of
operating income for 2016. A consolidated income statement, balance sheet, cash
flow statement and statement of changes in equity of Biocartis Group NV is
presented in the paragraph 'Financial information' at the end of this press
release.
Please find an overview of the key figures tables in the full version of the
press release in attachment.
Income statement
In 2016, collaboration revenues, predominantly consisting of recognized upfront
license revenues and milestone revenues from strategic partners, amounted to EUR
5.3m compared to EUR 9.7m in 2015, a decrease of approx. 46%. This was mainly
driven by the fact that EUR 4.0m of one-off milestone payments were collected in
2015 versus EUR 332k of milestone payments that were received in 2016 (a
decrease of approx. 92%). Recognized upfront license revenues amounted to EUR
4.7m, representing a decrease of approx. 7%. Product sales revenues on the other
hand increased with approx. 88% in 2016 to EUR 6.8m from EUR 3.6m in 2015,
predominantly driven by higher cartridge sales for commercial purposes.
Recognized grants and other income in 2016 amounted to EUR 1.7m being a 3.5%
increase compared to 2015. During 2016, Biocartis obtained two new grants for a
total amount of EUR 3.9m, consisting of a EUR 2.5m strategic grant from the
Flemish Agency for Innovation & Entrepreneurship under its Strategic
Transformation Support ('STS') program to support manufacturing expansion
capacity (18 October 2016) and a EUR 1.4m grant from VLAIO, the Flanders
organization for Innovation & Entrepreneurship, to support development of its
rapid NGS Prep Panels (31 October 2016). Of these grants, EUR 0.4m was
recognized in 2016.
Total operating income in 2016 consequently amounted to EUR 13.8m compared to
EUR 15.0m in 2015.
Total operating expenses in 2016 amounted to EUR 63.9m compared to EUR 54.6m in
2015, an increase of 17%. This included EUR 5.7m of cost of sales compared to
EUR 2.6m in 2015, driven by the increase in product sales revenues in 2016.
Excluding cost of sales, operating expenses increased in 2016 from EUR 52.0m in
2015 to EUR 58.2m, an increase of 12.1% driven by higher expenses in R&D and
Marketing & Distribution and lower expenses for General & Administrative (G&A).
R&D expenses increased from EUR 36.6m in 2015 with 15.1% in 2016 to EUR 42.1m.
This as the consequence of increased staffing (and related costs) as well as
increased R&D activities for test and platform development which were partially
offset by lower expenses for subcontracting. The increase in staffing and
related costs was driven by the 38 headcount increase of the R&D team in 2015
(majority was only recruited towards the end of 2015, staffing costs for these
employees consequently only had a full year impact as of 2016) as well as a
headcount increase of the R&D team with 5 employees in 2016.
Marketing and Distribution expenses increased from EUR 8.7m in 2015 to EUR
10.3m in 2016 (18.0% increase) as a result of an expansion of the Marketing &
Distribution team and increased sales and promotional expenses. During 2016, the
Marketing & Distribution team was expanded with 16 employees of which several
were already externally sourced from Janssen Pharmaceutica NV since 2015. That
has also been the main reason for the decreased subcontracting costs in 2016.
G&A expenses decreased in 2016 with 12.5% to EUR 5.8m (EUR 6.7m in 2015) due to
lower expenses for external advice (2015 was exceptionally impacted by the
Company's IPO in April 2015), facilities & office and human resources that were
partially offset by increased staff costs.
The operational result in 2016 amounted to a loss of EUR 50.2m compared to a
loss of EUR 39.7m in 2015. As a result of the foregoing, the loss for the year
after taxes increased from EUR 39.8m in 2015 to EUR 49.7m in 2016.
Balance sheet
Property plant & equipment predominantly consist, amongst others, of
manufacturing equipment (including equipment owned by Biocartis, equipment held
under lease and equipment that is under construction for the expansion of its
current cartridge manufacturing line and for the building of its second
cartridge manufacturing line), Idylla(TM) systems placed at clients (under
operational lease contracts or rental contracts) or held for internal use as
well as laboratory & ICT equipment. In 2016, property, plant & equipment
increased with EUR 8.8m from EUR 14.2m in 2015 to EUR 23.1m as the results of
investments (net, after disposals) of EUR 12.6m and depreciation of EUR 3.8m.
Investments predominantly consisted of manufacturing equipment and Idylla(TM)
systems for internal use and systems placed at clients under operational lease
contracts or rental contracts.
Deferred tax assets per 31 December 2016 amounted to EUR 3.1m and relate to tax
credits for research and development in Belgium.
Inventory increased from EUR 5.8m in 2015 to EUR 9.8m end of 2016 mainly driven
by higher levels of raw materials and semi-finished products in view of the
increased commercial cartridge volumes. Finished products included cartridges
and systems held for expected commercialization, including systems placed at
customers under the Company's early adopter program.
Trade receivables decreased in 2016 with EUR 2.9m from EUR 5.9m in 2015 to EUR
2.9m mainly driven by collection of milestone and upfront payments from
strategic partners. Other receivables related to VAT receivables and capital
grants and amounted EUR 2.2m as per end of 2016. Other current assets included
accrued grant income and deferred charges and increased in 2016 to EUR 1.9m
compared to EUR 1.3m in 2015.
The Company's cash and cash equivalents end of 2016 amounted to EUR 83.2m
compared to EUR 104.1m end of 2015.
Total financial debt amounted to EUR 31.4m as per end of 2016, representing an
increase of EUR 20.6m compared to the EUR 10.8m of total financial debt
outstanding end of 2015. The increase is for EUR 12.6m related to obtained lease
financing for the funding of investments for Biocartis' current and second
cartridge manufacturing line. Furthermore, EUR 8.1m is related to the new
subordinated loan of EUR 15.0m that the Company attracted in July 2016 to
refinance an existing subordinated loan (nominal amount of EUR 5m, excluding
accrued interest charges) that was due end of 2016. The current portion of
financial debt as per 31 December 2016 amounted to EUR 3.7m and the non-current
portion to EUR 27.7m.
Trade payables end of 2016 amounted to EUR 6.3m, representing a decrease of EUR
-7.6m compared to the EUR 13.9m that was outstanding end of 2015. This decrease
was predominantly driven by invoices received in 2015 for manufacturing
expansion that were paid for in 2016. Deferred income decreased in 2016 to EUR
2.1m (EUR 5.2m end of 2015), mainly because of recognized upfront payments from
Janssen Pharmaceutica in relation to the strategic licensing, development and
commercialization collaborations.
Cash flow statement
The cash flow from operating activities amounted to EUR -53.4m in 2016 compared
to EUR -27.3m in 2015 driven by an increased loss for the period (predominantly
due to higher operational expenses) in combination with investments in working
capital in 2016 compared to significant positive moments in working capital for
2015.
The cash flow from investing activities in 2016 amounted to EUR -9.3m compared
to EUR -5.4m in 2015 principally driven by increased investments for the
cartridge manufacturing expansion and higher investments in intangible assets,
mainly consisting of software and IP licenses.
The cash flow from financing activities in 2016 amounted to EUR 41.8m driven by
the net proceeds from the private placement in November 2016 and proceeds from
new borrowings, as well as the proceeds received from the Company's lease
financing provider related to manufacturing equipment that was initially paid
for by Biocartis and afterwards re-financed with lease financing. The cash flow
from financing activities in 2015 amounted to EUR 125.9m, which was
exceptionally impacted by the net proceeds from the Company's IPO in April 2015.
Driven by the aforementioned, the total net cash flow in 2016 amounted to EUR
-20.9m compared to EUR 93.2m in 2015.
Financial calendar 2017
* Capital Markets Day - 2 March 2017
* Publication annual report 2016 - 30 March 2017
* Q1 2017 business update - 27 April 2017
* Annual General Meeting Biocartis Group - 12 May 2017
* H1 2017 results - 7 September 2017
* Q3 2017 business update - 16 November 2017
Webcast and presentation
Biocartis will host a conference call with live webcast, during which the 2016
results will be presented, followed by a Q&A session. This event will be held
today, 2 March 2017 at 14:00 CET / 13:00 BST (UK) / 08:00 EDT (US). Access the
webcast by clicking here. If you would like to participate in the Q&A, please
dial +44(0)20 3427 1901 (standard international) with confirmation code
9539312. A replay of the webcast will be available on the Biocartis investors'
website shortly after.
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 30 March 2017. The statutory auditor, Deloitte
Bedrijfsrevisoren /Reviseurs d'Entreprises, represented by Gert Vanhees, has
substantially completed the audit procedures on the IFRS consolidated statements
as of and for the year ended 31 December 2016, and has confirmed that the
consolidated balance sheet, the consolidated statements of comprehensive income,
cash flow and changes in shareholders' equity, included in this press release,
are consistent in all material aspects with the consolidated accounts from which
they have been derived.
Please find an overview of the Consolidated Income Statement, the Consolidated
Balance Sheet, the Consolidated Cash Flow Statement and the Consolidated
Statement of Changes in Shareholder Equity in the full version of the press
release in attachment.
--- END ---
More information:
Renate Degrave
Manager Corporate Communications & Investor Relations
e-mail rdegrave(at)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(TM) 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 launched the Idylla(TM) platform in 2014.
Biocartis is developing and marketing a rapidly expanding test menu addressing
key unmet clinical needs in oncology and infectious diseases. These areas
represent respectively the fastest growing and largest segments of the MDx
market worldwide. Today, Biocartis has eight oncology tests and two infectious
disease tests in its product menu. More information: www.biocartis.com. Press
Photo Library available here. Follow us on Twitter: (at)Biocartis_.
Certain statements, beliefs and opinions in this press release are forward-
looking, which reflect the Company or, as appropriate, the Company directors'
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.
As a result, the Company expressly disclaims any obligation or undertaking to
release any update 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. 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] See further under 'Performance studies'. An overview of the publications can
be found on www.biocartis.com.
[2] The collaboration announced on 3 February 2016 focused on selected reference
hospitals in Brazil, Canada, Colombia, Mexico, Saudi Arabia, Spain and Turkey.
[3] The collaboration does not include the US, China and Japan.
[4] It concerns a new set of mutations in the EGFR ectodomain. While the
commonly known EGFR mutations reside in the kinase domain of the EGFR receptor,
which is located inside the cell, the EGFR ectodomain is the portion of the
receptor located outside the cell, and represents the true receptor function
where EGF binds, and where anti-EGFR antibodies for the treatment of colorectal
cancer such as cetuximab and panitumumab engage the EGFR receptor and prevent
EGF binding.
[5] The analysis is done based on a slice of FFPE (formalin fixed paraffin
embedded) tumor.
[6] Janku et al. BRAF Mutation Testing in Cell-Free DNA from the Plasma of
Patients with Advanced Cancers Using a Rapid, Automated Molecular Diagnostics
System. Mol Cancer Ther (2016) 15(6): 1-8; Schreuer et al. Quantitative
assessment of BRAF V600 mutant cell-free tumor DNA from plasma as a diagnostic
and therapeutic biomarker in patients with BRAF V600 mutant melanoma. ASCO
2015; De Biase et al. 'Fully Automated PCR detection of KRAS Mutations on
Pancreatic Endoscopic Ultrasound Fine Needle Aspirates'. J Clin Pathol 2016;
Reijans et al. ESMO 2016, published on 6 October 2016; De Luca et al., J Clin
Pathol 2016; J.L. Sherwood et al., KRAS - ESMO Abstract 91 P: "Implications of
key differences across 12 KRAS mutation detection technologies and their
relevance in clinical practice", publically available on
https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-
10-10#2z95w; Ellen Vercauteren et al., NRAS - ESMO Abstract 1175P: "Ultra-rapid,
sensitive, and fully automated extended RAS testing for metastatic colorectal
cancer - evaluation of an NRAS/BRAF/EGFR492 module", publically available on
https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-
10-10#2z95w; Preliminary Performance Study based on Research data. Martin
Reijans et al., EGFR - ESMO Abstract 1173P: "Fully automated and sensitive
detection of EGFR exon 18, 19, 20 and 21 mutational status in less than 2.5
hours from a single FFPE slice", publically available on
https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286/2016-
10-10#2z95w; Jérôme Solassol et al., "Multi-Center Evaluation of the Fully
Automated PCR-Based Idylla(TM) KRAS Mutation Assay for Rapid KRAS Mutation
Status Determination on Formalin-Fixed Paraffin-Embedded Tissue of Human
Colorectal Cancer", available for download:
http://journals.plos.org/plosone/article/asset?id=10.1371/journal.pone.0163444.P
DF.
[7] James L. Sherwood, "Implications of Key Differences Across 12 KRAS Mutation
Detection Technologies and Their Relevance in Clinical Practice", first
presented at ESMO in October 2016.
[8] Section 510(k) of the Food, Drug and Cosmetic Act requires device
manufacturers who must register, to notify FDA of their intent to market a
medical device at least 90 days in advance. This is known as Premarket
Notification - also called PMN or 510(k).
[9] Research Use Only.
[10] Merck KGaA, Darmstadt, Germany.
[11] FFPE = formalin fixed paraffin embedded.
[12] Disruptions in DNA repair pathways predispose cells to accumulating DNA
damage. A growing body of evidence indicates that tumors accumulate
progressively more mutations in DNA repair proteins as cancers progress. DNA
repair mechanisms greatly affect the response to cytotoxic treatments, so
understanding those mechanisms and finding ways to turn dysregulated repair
processes against themselves to induce tumor death is the goal of all DNA repair
inhibition efforts. Source:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4125008/, last updated on 14
February 2017.
170301 Press Release 2016FY Results ENG-FINAL:
http://hugin.info/171641/R/2083645/785469.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biocartis Group NV via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 02.03.2017 - 07:01 Uhr
Sprache: Deutsch
News-ID 527602
Anzahl Zeichen: 43594
contact information:
Town:
Mechelen
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 317 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Biocartis Group NV: Biocartis announces 2016 results, 2017 outlook and change in CEO position"
steht unter der journalistisch-redaktionellen Verantwortung von
Biocartis Group NV (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
