Press release Biocartis Group NV: Biocartis announces 2022 results
and 2023 outlook
PRESS RELEASE - REGULATED INFORMATION23
February 2023, 07:00 CET
BIOCARTIS
ANNOUNCES 2022
RESULTS AND 2023 OUTLOOK
The Company will host a conference call with live
webcast presentation today at 14:30 CET / 13:30 GMT (UK) / 08:30
EST (US) to discuss the full year 2022 results
Mechelen, Belgium, 23
February 2023 – Biocartis Group NV (the ‘Company’ or
‘Biocartis’), an innovative molecular diagnostics company (Euronext
Brussels: BCART), today announces its operational highlights and
financial results for 2022, prepared in accordance with IFRS as
adopted by the European Union, as well as selected post period
events and its outlook for 2023.
Commenting on the 2022
results and post-reporting period events, Herman
Verrelst, Chief Executive Officer of Biocartis,
said: “2022 was a successful
year, both operationally and financially. In a troubled
macroeconomic environment, we continued to scale our core oncology
business and delivered on our financial objectives with strong 30%
growth of oncology revenues, a doubling of the gross margin on
product sales to 34%, and a sizeable EUR 18.1m or 32% reduction of
our operating cash burn. Furthermore, we laid solid foundation for
continued future growth. The regulatory approval of the Idylla™
instrument in China and of the Idylla™ MSI Test as a companion
diagnostic test (CDx1) in Japan will broaden our global commercial
footprint. The extension of the collaboration with AstraZeneca
aimed at developing a CDx for Tagrisso® and the commercialization
of SkylineDx’s Merlin™ Assay and Ophiomics’ HepatoPredict show that
partnerships are a powerful means to rapidly expand the menu of
oncology tests and to make it available to any lab. Now that we
also successfully recapitalized the company with EUR 66m of gross
cash proceeds and a strengthened capital structure, we are in a
strong position to take another significant step towards
profitability. Several new regulatory approvals and new product
launches are planned for 2023, including the launch of the Idylla™
IDH1-2 Mutation Assay Kit (RUO), the first assay developed with our
new Idylla™ FLEX technology that significantly shortens development
times and that will allow us to bring more tests to the market
faster. While we are likely to operate in a continued unstable
economic climate, we took measures towards the end of 2022 to
weather the impact of significant cost inflation, and we are
confident that in 2023 we will continue to grow product related
revenues, again improve the gross margin on product sales and
further reduce the operating cash burn.”
KEY MESSAGES
2022 RESULTS
- Total
operating income of EUR 58m
(2021: EUR 54.9), of which EUR 57.5m revenue, an increase of 19%
from EUR 48.3m in 2021
- Product revenue of
EUR 45m (2021: EUR 40.5m), of which EUR 35.9m from 334k cartridges
sold and EUR 9.2m from instrument rentals and sales:
- EUR 31.3m cartridge revenue in
oncology, a 30% year-on-year increase, double-digit growth across
all regions, led by the US, both in cartridge volumes and in
average selling price (ASP)
- COVID-19 testing needs were fading,
decreasing the revenue contribution from SARS-CoV-2 tests to EUR
3.5m
- Continued increase of ASP per
commercial cartridge to EUR 106 (2021: EUR 96). Oncology ASP at EUR
116 (+11%)
- Global Idylla™ installed base of
2,085 instruments, 173 net new instruments placed
- Gross
profit on product sales increased
from EUR 6.6m in 2021 to EUR 15.2m in 2022, an increase of 132%
reflecting a gross margin of 34%, compared to 16% in 2021
- Operating cash
burn2 of EUR -38.5m, a reduction of more than a third or
EUR 18.1m lower than in 2021
- Comprehensive
recapitalization:
- EUR 66m gross cash proceeds across
convertible debt (EUR 41m) and equity (EUR 25m)
- Convertible debt restructured and
extended by 2.5 years
- Fully completed post the reporting
period on 16 January 2023, adding EUR 36.1m to the year-end cash
position of EUR 26.1m
-
Partnerships:
- Extension of the
collaboration with AstraZeneca aimed at developing
a companion diagnostic (CDx) for use with Tagrisso® (osimertinib),
AstraZeneca’s third-generation EGFR-TKI (tyrosine kinase inhibitor)
treatment
- Start of Biocartis’
commercialization in Europe of
SkylineDx’s Merlin Assay as a CE-IVD, ahead of the
launch of an Idylla™ version of the Assay
2023 OUTLOOKBuilding on the
strong performance of 2022, Biocartis expects to take a next
significant step towards operating profitability, with:
- Product related revenues3 of
between EUR 55m and EUR 60m, reflecting growth of 25%-35% when
excluding sales of SARS-CoV-2 tests that are expected to further
decrease
- A gross margin on product sales4 of
between 40% and 45%
- EBITDA of between EUR -25m and EUR
-28m, an improvement of between EUR 8.5m to EUR 11.5m
These projections are based on current foreign
currency exchange rates.
Biocartis will host a
conference call with live webcast presentation today at 14:30 CET /
13:30 GMT (UK) / 08:30 EST (US) to discuss the full year 2022
results. The live webcast presentation will be available through
this link on the day of the event. Only
participants who want to ask a question and/or follow the event
over the phone, are requested to register for the webcast
presentation here. Upon registration, each participant will be
provided with dial-in numbers and a unique personal PIN. 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
- 334k cartridges sold in 2022,
compared to 326k in 2021: 14% year-on-year growth in oncology,
offset by the continued decrease of COVID-19 testing, causing
volumes in infectious disease to decrease by 36% year-on-year
- Oncology cartridge revenues grew
30% in 2022: double-digit growth of cartridge volumes across all
regions coupled with a consistently increasing ASP of EUR 116
(+11%):
- Sustained growth across Europe with
growing adoption of the higher-priced Idylla™ GeneFusion Panel in
routine clinical use since its launch in June 2022
- The US continues to combine the
highest growth of oncology cartridge volumes with sustained pricing
discipline. Several new customers among the top 10 cancer centers
adopted Idylla™ in 2022. The ASP in oncology, traditionally higher
in the US than in our other markets, benefitted from a favorable
product mix and a smaller proportion of free-of-charge cartridge
volumes for market seeding and the initial validation of
assays
- Strong performance of the
distributor markets5 supported by the commercial agreement with
AstraZeneca aimed at increasing access to Idylla™ EGFR testing
products for patients with non-small cell lung cancer
- Total revenue from Idylla™
instruments increased by 3% to EUR 9.2m in 2022, including
instruments sold to content partners6:
- Revenue generated from instrument
placements at end customers increased by 36% year-on-year, against
a 9% increase of the installed base of Idylla™ instruments, which
is evenly split between sold and rented instruments
- Certain clinical trials that were
planned to start in 2022 and requiring the sale of a significant
number of Idylla™ instruments were delayed by our content partners
in light of the uncertain economic environment
- Instrument revenue in the US more
than doubled, even though several new customers deferred the
investment decision and adopted Idylla™ through Biocartis’
free-of-charge evaluation program under which they can temporarily
use the instrument while only paying for the cartridge consumption.
Subject to the favorable outcome of the evaluation, revenues from
the ultimate sale or rental of such instruments are therefore
delayed by 6 months on average
- 173 net new instruments placed.
Several instruments were reclaimed following a focused review of
non-performing reagent rental agreements to eliminate
non-profitable investments in capital expenditure
Idylla™ test menu,
partnerships & publications
- Test menu:
- Launch of the fully automated,
CE-marked IVD Idylla™ GeneFusion Panel on 20 June 2022
- Launch of new SeptiCyte RAPID®
(CE-IVD) EDTA7 blood compatible cartridges8 by Biocartis’ partner
Immunexpress on 23 August 2022
- Start of the commercialization on 1
September 2022 in Europe of SkylineDx’s innovative Merlin Assay as
a CE-IVD marked manual kit, ahead of the launch of an Idylla™
version of the Assay
- Product registrations:
- Japan – On 29 August 2022, Nichirei
Biosciences, Biocartis’ distribution partner in Japan, received
approval by the Japanese regulatory authorities (Ministry of
Health, Labor and Welfare) for the commercialization of the Idylla™
MSI Test in Japan. Nichirei Biosciences plans the commercial launch
of the Idylla™ MSI Test as a CDx in Japan in Q1 2023
- China – Regulatory approval of the
Idylla™ instrument on 16 September 2022 by the Chinese regulatory
authorities NMPA, an important step towards the further regulatory
and commercialization of Idylla™ assays in China
- Partnerships:
- Announcement of a new partnership
on 8 February 2022 between Biocartis and Ophiomics, a Lisbon
(Portugal) based biotech company with an initial focus on the
commercialization of HepatoPredict9. The commercialization in
Europe of the test as a CE-marked IVD kit started on 10 October
2022
- Announcement of an extension of the
collaboration with AstraZeneca on 22 June 2022 highlighting the
development and planned premarket submission to the US FDA of a
novel CDx test on the Idylla™ platform for AstraZeneca’s
third-generation EGFR-TKI (tyrosine kinase inhibitor)
treatment
- Publications - During 2022, 42 new
papers with excellent data were published on several new Idylla™
studies, including:
- A study (announced 4 May 2022) by
Memorial Sloan Kettering Cancer Center (NY, US), in the Journal of
Molecular Diagnostics on the Idylla™ GeneFusion Assay (RUO10),
highlighting the quicker turnaround and the lower tissue
requirements compared to immunohistochemistry and molecular
methods, while also circumventing the infrastructure dependencies
associated with NGS and fluorescence in situ hybridization.
- A large prospective study
(announced 8 November 2022) demonstrating that the Idylla™ EGFR
Mutation Test (CE-IVD) leads to the significant reduction of the
time-to-treatment by on average 16.8 days or 48% compared to NGS
testing for EGFR positive patients
Organizational and operational
highlights
- Commercial milestones – Double
milestone announced on 15 June 2022 with the selling of the
1,000,000th commercial Idylla™ cartridge and the placement of the
2,000th Idylla™ instrument since commercial launch
- Shareholders’ Meetings – All agenda
items were approved during the ordinary shareholders’ meeting held
13 May 2022 and the extraordinary shareholders’ meeting held 14
November 2022 which approved the various components of the
Company’s comprehensive recapitalization
- Cartridge manufacturing – Except
for the Septicyte RAPID® test, the transfer of all assays to the
second cartridge manufacturing line (‘ML2’) was completed during
2022, further unlocking economies of scale and reducing
manufacturing costs
- ISO 27001 certification – ISO 27001
certification of Biocartis announced on 24 August 2022 for the
design, development, maintenance, service provision and support of
the Idylla™ platform and associated customer-facing software
- Management team – Biocartis aligned
its organizational structure to deliver on its strategic priorities
and has appointed, effective as from 1 September 2022:
- Global Head of Partnering:
Madhushree (Madhu) Ghosh, PhD, MS, joined Biocartis as Global Head
of Partnering. Dr. Ghosh brings a wealth of experience to
successful commercial and strategic team leadership in global
strategic alliance management, P/L business unit leadership and IVD
and CDx product development for more than 20 years spent in
molecular diagnostics and clinical assay development with a focus
on Next Generation Sequencing, real-time PCR, multiplex PCR,
oncology and infectious disease diagnostics. Previously, Dr. Ghosh
held senior roles at Thermo Fisher Scientific, NeoGenomics
Laboratories Inc., QIAGEN, and AltheaDx.
- Global Head of Sales: David Dejans,
previously Head of Sales Europe and Distributor markets, moved into
the role of Global Head of Sales
- In Q4 2022, the organization was
streamlined across all areas of the business to withstand the
impact of the significant cost inflation. Compared to 31 December
2021, the workforce decreased by 16%
Financial highlights
- Total operating income – Total
operating income amounted to EUR 58m, compared to EUR 54.9m in
2021, and included EUR 45m from product sales (2021: EUR 40.5m;
+11%), EUR 11.1m from various collaborations with partners (2021:
EUR 6.1m; +83%), EUR 1.4m from instrument servicing (2021: EUR
1.7m; -20%) and EUR 0.5m other income (2021: EUR 6.6m; -93%)
- Revenues from cartridge sales grew
13% year-on-year to EUR 35.9m. Cartridge sales in the core oncology
business increased by 30%, while sales of the SARS-CoV-2 cartridges
decreased by 49% and only represented 7.7% of total product
revenues. 334k cartridges were sold in 2022 (2021: 326k) at an ASP
of EUR 106 (2021: EUR 96).
- The strong 30% growth of oncology
cartridge revenue resulted from growing cartridge volumes (+14%
year-on-year) and an increased ASP of EUR 116, compared to EUR 105
in 2021. The ASP in oncology continues to develop favorably as the
contribution from high value-adding assays such as the IdyllaTM
Genefusion Assay (RUO) continues to increase. A continued focus on
pricing discipline and a gradually increasing contribution from
sales in the US where prices are generally higher than in Europe
and other parts of the world, also support the steady increase of
the cartridge ASP. Conversely, the fading COVID-19 testing need
resulted in 36% lower cartridge volumes in infectious diseases,
while the ASP of EUR 63 also decreased 18% year-on-year
- Revenues from the sale and rental
of the IdyllaTM instrument amounted to EUR 9.2m, a 3% increase
year-on-year. The installed base grew with 173 instruments to 2,085
instruments, net of conversions from instruments previously placed
free-of-charge under short-term evaluation programs and returns of
non-performing instruments under reagent rental agreements aimed at
reducing non-profitable capital investments. As a direct result of
the uncertain economic climate, the planned sale of a significant
number of instruments was delayed following the decision by certain
content partners to delay clinical trials that were planned to
start in 2022
- Income from collaborations amounted
to EUR 11.1m compared to EUR 6.1m in 2021, and mainly included
R&D services provided to our pharma and content partners, aimed
at expanding the Idylla™ test menu and at developing companion
diagnostic tests that will unlock additional market potential in
the US and in other markets
- Other income of EUR 0.5m related to
grants received in connection with the development of the new
IdyllaTM FLEX technology that is expected to facilitate the use of
IdyllaTM tests in therapy decisions and molecular surveillance. The
first product that is based on this Idylla™ FLEX technology, the
Idylla™ IDH1-2 Mutation Assay Kit (RUO), was launched in 2023. In
2021, other income included an insurance claim of EUR 4.6m for
damages caused by the fire in a warehouse in July 2021
- Cost of goods sold – Cost of goods
sold decreased by 12% to EUR 29.8m, while cartridge volumes and the
number of newly placed instruments remained comparable to 2021.
Contrary to 2021, a year of disrupted reagent supply and the
temporary unavailability of manufacturing capacity caused by the
fire in one of Biocartis’ warehouses, most cartridges were produced
on the high-throughput automated manufacturing line ML2 in 2022,
unlocking significant economies of scale. The gross margin on
product sales more than doubled from 16% in 2021 to 34% in 2022, as
a direct result of lower manufacturing costs per cartridge and the
lower contribution of low-priced SARS-CoV-2 tests. In the first
quarter of 2023, more than 90% of the commercial cartridge
production will have been transferred to ML2 and a plan to fully
decommission ML1 will be implemented over the year
- OPEX – Total operating expenses,
excluding the cost of goods sold, decreased 10% year-on-year from
EUR 83.6m to EUR 75.2m. Apart from the fire damages of EUR 3.2m
incurred in 2021, operating expenses decreased by EUR 5.2m, despite
the impact of global inflation. Investments in various R&D
programs were cut back by EUR 9.7m. The increase of EUR 3.8m in
sales & marketing reflected normalized commercial activities
post the pandemic and the full year impact of the restructuring of
the US commercial operations implemented at the end of 2021.
General & administrative spending levels remained stable at EUR
16.2m, an increase of 4% year-on-year that merely reflected cost
inflation. In Q4 of 2022, the organization was streamlined to
offset the expected continued inflation of costs in 2023, including
the mandatory indexation of salaries in Belgium of 11%, effective
January 2023. Among others, the workforce was reduced by 16% across
the entire organization since 31 December 2021
- Recapitalization – On 1 September
2022, Biocartis launched a comprehensive recapitalization,
providing EUR 66m of gross proceeds and comprising:
- the amendment of the existing 4%
convertible bonds of EUR 135m, including a.o. the mandatory
conversion of 10% of these convertible bonds into common shares at
the conversion rate of EUR 12.89 and the extension of the maturity
date until 9 November 2027
- a new first lien secured
convertible term loan of EUR 30.1m, partly used for the buy-back of
EUR 16.3m of existing 4% convertible bonds for EUR 13.7m in
cash
- an exchange of the amended existing
convertible bonds for new 4.5% second lien secured convertible
bonds, subject to the subscription of EUR 25m of additional newly
issued 4.5% convertible bonds, and
- a rights offering with extra-legal
preferential rights for the existing shareholders of the Company of
EUR 25.1m
On 31 December 2022, the recapitalization
transactions were partly completed. Following the amendment, the
buy-back and the exchange offer, EUR 14.8m of existing 4%
convertible bonds remained outstanding and EUR 92.1m of the 4%
convertible bonds had been exchanged for the new 4.5% convertible
bonds. EUR 18.1m was drawn under the new convertible term loan and
33,476,932 new shares were issued on 2 December 2022 through a
rights offering of EUR 25.1m. Post year-end, the recapitalization
completed on 16 January 2023 with the second drawdown of EUR 12m
under the new convertible term loan and the funding of the
additional new 4.5% convertible bonds for EUR 25m
- Financial results – The net
financial expense of EUR 0.01m included the impact of the
recapitalization. In accordance with IFRS, the amendment and the
exchange were considered as an extinguishment of the existing 4%
convertible bond and the issuance of the new 4.5% convertible bond.
The difference between the derecognition of the existing
convertible bond and the new convertible bond was recorded as a
gain of EUR 10.5m in the income statement. The interest and debt
appreciation expense associated with the convertible term loan and
the two convertible bonds amounted to EUR 10.2m
- Cash flows and cash balance – The
cash flow from operating and investing activities amounted to EUR
-50.3m, a significant reduction of EUR 19.2m compared to EUR 69.5m
in 2021. The reduction resulted from a.o. (a) EUR 15.6m improvement
of the operating result, (b) EUR 5.8m lower investments in working
capital, (c) EUR 1.8m lower capital expenditure, offset by (d)
investments in the Chinese joint venture Wondfo-Cartis (EUR 1m) and
in a convertible note issued by SkylineDx (of which EUR 2.5m was
already made available by Biocartis). The net proceeds from
financing activities of EUR 22.5m reflected (a) a net new drawdown
of EUR 9m on working capital facilities from KBC Bank, (b) EUR
18.1m proceeds from the first drawdown under the new convertible
term loans, (c) the cash buy-back of existing convertible bonds for
EUR 13.7m, (d) the scheduled reimbursement of EUR 6.6m of lease
obligations, (e) EUR 25.1m proceeds of the rights issue, net of (f)
EUR 9.6m fees associated with the recapitalization transactions.
The cash and cash equivalents at 31 December 2022 amounted to EUR
26.1m.
Post year-end, the recapitalization transaction
was completed on 16 January 2023, adding EUR 36.1m of net cash,
from the second drawdown on the convertible term loan and the
issuance of EUR 25m of additional 4.5% convertible bonds
- Balance sheet – In accordance with
IFRS 9, the new 4.5% convertible bonds were partly recorded as a
liability and partly as equity. Following the recapitalization
transactions, the financial indebtedness at 31 December 2022
amounted to EUR 117.8m compared to EUR 154.2m at 31 December 2021.
The shareholders’ equity increased by EUR 8.2m as a result of a.o.
(a) the recognition of EUR 22.8m equity value attributed to the new
convertible bond, (b) the issuance of new shares for EUR 23m, net
of fees, following the rights offering and (c) the loss for the
year of EUR 47.7m
KEY FIGURES
2022 The tables below show an overview of the key
figures and a breakdown of operating income for 2022 and 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’ below.
Key figures (EUR 1,000) |
2022 |
2021 |
% Change |
Total operating income |
57,976 |
54,898 |
6% |
Cost of sales |
-29,799 |
-33,922 |
-12% |
Research and development expenses |
-38,393 |
-48,054 |
-20% |
Sales and marketing expenses |
-20,595 |
-16,763 |
23% |
General and administrative expenses |
-16,236 |
-15,560 |
4% |
Other expenses |
- |
-3,244 |
|
Operating expenses |
-105,023 |
-117,543 |
-11% |
Operating result |
-47,047 |
-62,645 |
-25% |
Net financial result |
10 |
-8,411 |
-100% |
Share in the result of associated companies |
-884 |
-659 |
34% |
Income tax |
240 |
243 |
-1% |
Net result |
-47,681 |
-71,472 |
-33% |
Cash flow from operating activities |
-44,855 |
-65,716 |
-32% |
Cash flow from investing activities |
-5,431 |
-3,748 |
45% |
Cash flow from financing activities |
22,463 |
-1,204 |
-1,965% |
Net cash flow 1 |
-27,823 |
-70,668 |
-61% |
Cash and cash equivalents2 |
26,125 |
53,522 |
-51% |
Financial debt |
117,803 |
154,162 |
-24% |
1 Excludes the effect of exchange rate
differences on the cash balances held in foreign currencies 2
Including EUR 1,2m of restricted cash in 2022 & 2021
Operating income (EUR 1,000) |
2022 |
2021 |
% Change |
Collaboration revenue |
11,068 |
6,053 |
83% |
Idylla™ system sales and rentals |
9,172 |
8,869 |
3% |
Idylla™ cartridge sales |
35,864 |
31,618 |
13% |
Product sales revenue |
45,036 |
40,486 |
11% |
Service revenue |
1,377 |
1,730 |
-20% |
Total revenue |
57,481 |
48,269 |
19% |
Grants and other income |
495 |
6,629 |
-93% |
Total operating income |
57,976 |
54,898 |
6% |
IDYLLA™ TEST
MENU OUTLOOKIn 2023, Biocartis expects to achieve
certain regulatory milestones and to launch the assays listed
below. The timing of the planned launch of partner tests remains
subject to changes imposed by the relevant partners:
- Idylla™ MSI Test – 510(k) pending
review by the US FDA
- SeptiCyte® RAPID on Idylla™ EDTA –
submission of 510(k) to the US FDA (in collaboration with
Immunexpress)
- Idylla™ IDH1-2 Mutation Assay Kit
Test (RUO) – Global availability to all customers
- Idylla™ PIK3CA-AKT1 Mutation Assay
– RUO in collaboration with LifeArc
- Idylla™Merlin CP-GEP Assay – RUO in
collaboration with SkylineDx
- Idylla™ ThyroidPrint Assay – RUO in
collaboration with GeneproDx
POST-PERIOD EVENTS
- Announcement on 16 January 2023 of
the completion of the final steps of the comprehensive
recapitalization transactions
- Announcement on 9 February 2023 of
the launch among selected customers of the Idylla™ IDH1-2 Mutation
Assay Kit Test (RUO), the first test developed with the new Idylla™
FLEX technology that separates the generic components of an Idylla™
test from the test-specific components
- Announcement on 22 February 2023 of
the resignation of Mr. Roald Borré as Director of the Company and
the appointment of Mr. Bryan Dechairo as a new independent Board
member and member of the Audit Committee of the Company
FINANCIAL CALENDAR
- 30 March 2023
Publication Annual Report 2022
- 20 April 2023
Q1 2023 Business Update
- 12 May 2023
Annual General Shareholders’
Meeting Biocartis Group NV
- 31 August 2023
H1 2023 results
- 9 November 2023
Q3 2023 Business Update
Financial informationThe
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 2023. The
financial information in this press release was not audited by the
statutory auditor.
Consolidated
income
statement
|
Years ended 31 December |
In EUR 000 |
2022 |
|
2021 |
|
|
|
|
Revenue |
|
|
|
Collaboration revenue |
11,068 |
|
6,053 |
Product sales revenue |
45,036 |
|
40,486 |
Service revenue |
1,377 |
|
1,730 |
|
57,481 |
|
48,269 |
Other operating income |
|
|
|
Grants and other income |
495 |
|
6,629 |
|
|
|
|
Total operating income |
57,976 |
|
54,898 |
|
|
|
|
Operating expenses |
|
|
|
Cost of sales |
-29,799 |
|
-33,922 |
Research and development expenses |
-38,393 |
|
-48,054 |
Sales and marketing expenses |
-20,595 |
|
-16,763 |
General and administrative expenses |
-16,236 |
|
-15,560 |
Other expenses |
0 |
|
-3,244 |
|
-105,023 |
|
-117,543 |
|
|
|
|
Operating loss for the year |
-47,047 |
|
-62,645 |
|
|
|
|
Financial expense |
-11,289 |
|
-9,488 |
Other financial results |
11,299 |
|
1,077 |
Financial result, net |
10 |
|
-8,411 |
|
|
|
|
Share in the results of associates |
-884 |
|
-659 |
|
|
|
|
Loss for the year before taxes |
-47,921 |
|
-71,715 |
Income taxes |
240 |
|
243 |
Loss for the year after taxes |
-47,681 |
|
-71,472 |
|
|
|
|
Attributable to owners of the Company |
-47,681 |
|
-71,472 |
Attributable to non-controlling interest |
|
|
|
|
|
|
|
Earnings per share |
|
|
|
Basic and diluted loss per share |
-0.79 |
|
-1.26 |
Consolidated
balance
sheet
|
|
As of 31 December |
In EUR 000 |
2022 |
|
2021 |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Non-current assets |
|
|
|
|
Intangible assets |
4,770 |
|
5,067 |
|
Property plant and equipment |
31,527 |
|
37,192 |
|
Financial assets |
3,640 |
|
1,140 |
|
Investment joint ventures |
2,538 |
|
2,344 |
|
Other non-current receivables |
204 |
|
16 |
|
Deferred tax assets |
1,664 |
|
1,595 |
|
|
44,343 |
|
47,354 |
|
|
|
|
|
|
Current assets |
|
|
|
|
Inventories |
18,905 |
|
16,106 |
|
Trade receivables |
16,697 |
|
16,206 |
|
Other receivables |
2,236 |
|
6,556 |
|
Other current assets |
5,971 |
|
2,736 |
|
Cash and cash equivalents* |
26,125 |
|
53,522 |
|
|
69,934 |
|
95,126 |
|
|
|
|
|
|
Total assets |
114,277 |
|
142,480 |
|
|
|
|
|
Equity and liabilities |
|
|
|
|
|
|
|
|
|
Capital and reserves |
|
|
|
|
Share capital |
-220,302 |
|
-220,657 |
|
Share premium |
618,575 |
|
711,874 |
|
Share based payment reserve |
7,502 |
|
6,862 |
|
Accumulated deficit |
-425,663 |
|
-526,405 |
|
Other comprehensive income |
-5,843 |
|
-5,571 |
|
Total equity attributable to owners of the
Company |
-25,731 |
|
-33,897 |
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
Provisions |
204 |
|
75 |
|
Borrowings and lease liabilities |
25,824 |
|
14,133 |
|
Convertible debt |
71,382 |
|
128,151 |
|
Deferred income |
149 |
|
313 |
|
|
97,559 |
|
142,672 |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
Borrowings and lease liabilities |
20,597 |
|
11,878 |
|
Trade payables |
11,747 |
|
11,560 |
|
Deferred income |
1,195 |
|
1,822 |
|
Other current liabilities |
8,910 |
|
8,445 |
|
|
42,449 |
|
33,705 |
|
|
|
|
|
Total equity and liabilities |
114,277 |
|
142,480 |
* Cash and cash equivalents for 31 December 2021
and 2022 include EUR 1.2 million restricted cash related to KBC
Lease financing Consolidated cash flow
statement
|
Years ended 31 December |
In EUR 000 |
2022 |
|
2021 |
Operating activities |
|
|
|
|
|
|
|
Loss for the year |
-47,681 |
|
-71,472 |
|
|
|
|
Adjustments for |
|
|
|
Depreciation and amortization |
10,481 |
|
9,845 |
Impairment losses |
1,178 |
|
1,362 |
Income taxes in profit and loss |
-240 |
|
-243 |
Financial result, net |
-10 |
|
8,411 |
Unrealized exchange gains/ losses |
|
|
1,134 |
Net movement in defined benefit obligation |
-143 |
|
69 |
Share of net profit of associate and a joint venture |
884 |
|
659 |
Share based payment expense |
640 |
|
760 |
Other |
-78 |
|
-162 |
|
|
|
|
Changes in working capital |
|
|
|
Net movement in inventories |
-5,297 |
|
-2,737 |
Net movement in trade and other receivables and other current
assets |
1,579 |
|
-5,916 |
Net movement in trade payables & other current liabilities |
652 |
|
-1,489 |
Net movement in deferred income |
-791 |
|
494 |
|
-38,826 |
|
-59,285 |
|
|
|
|
Interests paid |
-6,027 |
|
-6,429 |
Taxes paid |
-2 |
|
-2 |
Cash flow used in operating activities |
-44,855 |
|
-65,716 |
|
|
|
|
Investing activities |
|
|
|
Interests received |
6 |
|
7 |
Acquisition of property, plant & equipment |
-1,569 |
|
-3,686 |
Acquisition of intangible assets |
-368 |
|
-69 |
Acquisition of investment in a joint venture |
-1,000 |
|
0 |
Investment convertible note |
-2,500 |
|
|
Cash flow used in investing activities |
-5,431 |
|
-3,748 |
|
|
|
|
Financing activities |
|
|
|
Proceeds from borrowings |
15,000 |
|
6,000 |
Refinancing transactions Convertible bond, convertible term
loan |
10,782 |
|
0 |
Net proceeds from the issue of common shares, net of transaction
costs |
23,055 |
|
0 |
Repayment of borrowings |
-26,301 |
|
-7,089 |
Bank charges |
-73 |
|
-115 |
Cash flow from financing activities |
22,463 |
|
-1,204 |
|
|
|
|
Net increase / (decrease) in cash and cash
equivalents |
-27,823 |
|
-70,668 |
|
|
|
|
Cash and cash equivalents at the beginning of the year |
53,522 |
|
123,668 |
Effects of exchange rate changes on the balance of cash held in
foreign currencies |
426 |
|
522 |
Cash and cash equivalents at the end of the
year* |
26,125 |
|
53,522 |
* 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 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 |
|
|
|
|
|
760 |
|
760 |
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as at 31 December 2021 |
|
|
-220,657 |
|
711,875 |
|
6,862 |
|
-5,571 |
|
-526,405 |
|
-33,897 |
|
-33,897 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as at 1 January 2022 |
|
|
-220,657 |
|
711,875 |
|
6,862 |
|
-5,571 |
|
-526,405 |
|
-33,897 |
|
-33,897 |
Loss for the period |
|
|
|
|
|
|
|
|
|
|
-47,681 |
|
-47,681 |
|
-47,681 |
Re-measurement gains and losses on defined benefit plan |
|
|
|
|
|
|
|
|
-272 |
|
|
|
-272 |
|
-272 |
Consolidation translation difference |
|
|
|
|
|
|
|
|
|
|
378 |
|
378 |
|
378 |
Total comprehensive income |
|
|
|
|
|
|
|
|
-272 |
|
-47,303 |
|
-47,574 |
|
-47,574 |
Share-based payment expense |
|
|
|
|
|
|
640 |
|
|
|
|
|
640 |
|
640 |
Convertible bond – conversion old bond |
|
|
|
|
-6,323 |
|
|
|
|
|
|
|
-6,323 |
|
-6,323 |
Convertible bond – issue new bond |
|
|
|
|
25,162 |
|
|
|
|
|
|
|
25,162 |
|
25,162 |
Share issue - rights offering |
|
|
336 |
|
24,773 |
|
|
|
|
|
|
|
25,108 |
|
25,108 |
Costs related to rights offering |
|
|
|
|
-2,053 |
|
|
|
|
|
|
|
-2,053 |
|
-2,053 |
Share issue - conversion convertible term loan |
|
|
2 |
|
240 |
|
|
|
|
|
|
|
242 |
|
242 |
Share issue - contribution in kind |
|
|
8 |
|
992 |
|
|
|
|
|
|
|
1,000 |
|
1,000 |
Share issue - mandatory conversion convertible bond |
|
|
9 |
|
11,956 |
|
|
|
|
|
|
|
11,965 |
|
11,965 |
Capital increase by contribution in kind |
|
|
|
|
-104,071 |
|
|
|
|
|
104,071 |
|
0 |
|
0 |
Capital decrease by incorporation of accumulated losses |
|
|
|
|
-43,975 |
|
|
|
|
|
43,975 |
|
0 |
|
0 |
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as at 31 December 2022 |
|
|
-220,302 |
|
618,574 |
|
7,502 |
|
-5,843 |
|
-425,663 |
|
-25,730 |
|
-25,730 |
--- END ---More
information:
e-mail ir@biocartis.com
@Biocartis_
www.linkedin.com/Biocartis
About BiocartisWith its
revolutionary and proprietary Idylla™ platform, Biocartis (Euronext
Brussels: BCART) aspires to enable personalized medicine for
patients around the world through universal access to molecular
testing, by making molecular testing actionable, convenient, fast
and suitable for any lab. The Idylla™ platform is a fully automated
sample-to-result, real-time PCR (Polymerase Chain Reaction) based
system designed to offer in-house access to accurate molecular
information in a minimum amount of time for faster, informed
treatment decisions. Idylla™'s continuously expanding menu of
molecular diagnostic tests address key unmet clinical needs, with a
focus in oncology. This is the fastest growing segment of the
molecular diagnostics market worldwide. Today, Biocartis offers
tests supporting melanoma, colorectal, lung and liver cancer, as
well as for COVID-19, Flu, RSV and sepsis. For more information,
visit www.biocartis.com or follow Biocartis on Twitter
@Biocartis_ , Facebook or LinkedIn. 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.
Impact of the war in
UkraineBiocartis has no sales in Ukraine. In Russia,
Biocartis works through a local sales distributor who realized
first commercial sales in H1 2021 following completion of first
product registrations in Russia in Q1 2021. The impact to expected
revenue for 2022 from Russian distributor sales that were projected
prior to the start of the war, is not material. Supplier exposure
is limited to one indirect supplier for Idylla™ instrument
sub-parts who is based in Russia. Based on the current level of
inventory on-hand and on various alternative sources of supply that
were identified and are currently being assessed, Biocartis does
not expect any material adverse impact on the continued supply of
instruments.
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 A companion diagnostic (CDx) is a medical device, often an in
vitro device, which provides information that is essential for the
safe and effective use of a corresponding drug or biological
product.
2 EBITDA + CAPEX (operating loss (EUR 47,047k) plus acquisition
of property, plant and equipment (EUR 1,569k) and intangible assets
(EUR 368k) minus depreciation and amortization (EUR 10,481k)3
Including revenue from instrument servicing4 Excluding revenue from
instrument servicing
5 Defined as the world excluding European direct
markets, US, China and Japan6 Partners providing test content so as
to develop an Idylla™ version of their assay or test on the Idylla™
platform7 EDTA represents Ethylenediaminetetraacetic acid, which is
the anticoagulant used for most hematology procedures (like
identifying and counting blood cells, blood typing, etc.). Source:
ksmedical.com, last consulted on 24 August 20228 In addition to
blood samples collected in PAXgene blood RNA tubes (per the
manufacturer’s instructions), this test is now also able to process
undiluted EDTA blood samples which are commonly used for most
hematology procedures, with results available in about one hour
9 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 Biocartis’ rapid and easy-to-use molecular diagnostics platform
Idylla™. HepatoPredict is a prognostic gene expression signature
test to help identify which patients will benefit from
curative-intent surgery, in particular liver transplantation10
Research Use Only, not for use in diagnostic procedures
Grafico Azioni Biocartis Group NV (EU:BCART)
Storico
Da Feb 2024 a Mar 2024
Grafico Azioni Biocartis Group NV (EU:BCART)
Storico
Da Mar 2023 a Mar 2024