Full Year 2023 Sales increased +42%1 to
€10.5m
€1.2m positive full-year operating
income
+47% growth in Q1 2024 in U.S. PPU
volume
Recent Telix strategic investment and
restructured EIB loan improve capital profile
2024 guidance set over +20% organic
sales growth, excluding licensing income
Webcast to be held today at 6:00 pm (in
French)
Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor
of Cellvizio®, the multidisciplinary probe and needle-based
confocal laser endomicroscopy (p/nCLE) platform, today reported its
financial results for the full year 2023 and its sales for the
first quarter 2024.
For full year 2023, total Group sales increased by 42% to
€10.5m, driven by the strong volume growth of the PPU business in
the U.S. and the substantial contribution of licensing sales. The
Group's operating income for 2023 significantly improved to €1.2m
(compared with a loss of -€9.1m in 2022), reflecting the positive
impact of the Group's strategic partnership with the Tasly J.V.
Cash and cash equivalents stood at €8.0m as of December 31,
2023, up €4.8m since December 31, 2022 notably thanks to the
capital increase reserved to Telix Pharmaceuticals.
In Q1 2024, the pay-per-use (PPU) business, which accounts for
50% of sales in the United States, continued to track to the
favorable utilization trends observed in 2023, with volumes up 47%
year-on-year.
Commenting on the results, Sacha Loiseau, Ph.D., Chairman and
CEO of Mauna Kea Technologies observed, “2023 marks the
conclusion of an intensive period of transformation for the
Company, initiated in late 2021 with a focus on forging strategic
partnerships and enhancing the momentum and productivity of our
operations notably in the U.S. I am very pleased with the progress
we have made in delivering our commitments which include, on one
hand, the establishment of a strategic partnership with Tasly in
China and the expansion of our collaboration with Telix in
uro-oncology—now our leading shareholder, and on the other hand,
the operational excellence with a sustained increase in the number
of Cellvizio procedures in the United States, surpassing the
significant milestone of 1,000 procedures per quarter, alongside a
notable reduction in operating losses and strengthening of the
balance sheet.”
Highlights Full Year 2023
In 2023, Mauna Kea Technologies escalated its ambitious
transformation strategy initiated in late 2021, aiming to set the
company on a path of sustainable and profitable growth while
strengthening its financial structure.
(in €k) – IFRS
FY 2023
FY 2022
Change
€k
%
Total sales
10,480
7,479
+3,001
+40%
Gross margin
8,405
5,475
+2,930
+54%
Current operating income
(5,686)
(8,983)
+3,297
-37%
Operating income
1,231
(9,062)
+10,293
-
Net profit (loss)
(3,727)
(11,180)
+7,453
-67%
On the sales front, the company experienced significant
expansion in the U.S. market for PPU procedures, more effectively
meeting the expectations and needs of care centers compared to
traditional system sales. This approach proved to be also more
sustainable. Thanks to precise targeting and the enhanced
efficiency of the tightened sales team, activity progressively
increased over the year, with average monthly usage doubling
compared to the start of the year. This trend continued into the
first quarter of 2024, with procedure volumes increasing by 47%
compared to the previous year.
To leverage its technology in new indications and territories,
the company also formed a joint venture in China with Tasly
Pharmaceutical. This strategic collaboration is allowing rapid
access to a significant commercial potential in the Chinese market,
while also facilitating technological expansion in neurology and
neurosurgery. This partnership generated $9 million proceeds in
2023, of which $4.8 million were recognized in sales in 2023.
Financially, the company significantly reduced its operational
loss, thanks to an improvement in operational performance and cost
reduction initiatives, particularly in marketing and
administration. Thanks to a significant reduction in net loss and
the capital increase from Telix’s investment at the end of the
year, Mauna Kea’s financial structure has also been strengthened
with a significant reduction in equity deficit. Currently, Mauna
Kea is supported by two major strategic investors, Telix
Pharmaceuticals and Johnson & Johnson, who hold nearly 40% of
the capital. Furthermore, the company received increased support
from the European Investment Bank, which agreed to restructure its
€21.3 million debt and postpone final maturities by 4 years to 2028
and 20292.
On the technological front, Mauna Kea continues to invest in
R&D for its flagship product and recently partnered with V7, a
leading AI and data labeling company, to develop a cutting-edge
infrastructure for AI applications with Cellvizio.
2024 Priorities and Financial Guidance:
In 2024, Mauna Kea Technologies intends to confirm its growth
trajectory both through the sale of systems, probes and procedures
but also by forging new strategic partnerships. The Group will lean
on:
- The continued growth of the U.S. activity especially in PPU
with an emphasis in procedure volumes and the acquisition of new
accounts;
- The operational ramp-up of the JV in China and the first orders
for systems and probes;
- The full-scale commercial launch of the food intolerance
activity;
- The conclusion of new strategic partnerships.
The Group also sets financial targets for the year,
specifically:
- Over +20% sales growth excluding licensing income, driven by
volume growth in the U.S.;
- A two-fold increase in the production of Cellvizio systems to
meet demand across the different markets and to support the ramp-up
of the JV in China and the launch of the food intolerance
activity;
- A reduction in operational loss thanks to the growth of
activity and a continued cost cutting efforts;
- A strengthened financial structure.
Sacha Loiseau concluded, “2024 is the start of an
exciting phase of growth for the Company, driven by the ongoing
positive momentum in the United States in the field of esophageal
and gastric cancer, major clinical results in pancreatic cysts,
anticipated to contribute to incremental sales growth, the first
orders from our joint venture in China and the launch of our food
intolerance business. All these achievements and the solid
foundations laid over the past two years have created a strong
intrinsic value for Mauna Kea, which, while clear to our partners,
is not reflected in our current capitalization. We remain confident
that this will be the case in the near future, and thank our
long-term shareholders for their support. Resilience remains the
key to success.”
Consolidated Financial Statements
The Board of Directors approved the consolidated financial
statements on 24 April 2024. The consolidated financial statements
have been audited and the Statutory Auditors’ report is in the
process of being issued. Mauna Kea’s comprehensive audited
financial statements will be available in due course on
maunakeatech.com.
Webcast
A webcast for investors and analysts (held in French) will begin
today at 6pm CEST. Participants can access the webcast here.
About Mauna Kea Technologies Mauna Kea Technologies is a
global medical device company that manufactures and sells
Cellvizio®, the real-time in vivo cellular imaging platform. This
technology uniquely delivers in vivo cellular visualization which
enables physicians to monitor the progression of disease over time,
assess point-in-time reactions as they happen in real time,
classify indeterminate areas of concern, and guide surgical
interventions. The Cellvizio® platform is used globally across a
wide range of medical specialties and is making a transformative
change in the way physicians diagnose and treat patients. For more
information, visit www.maunakeatech.com.
Disclaimer can be found at the end of this document.
Additional Financial
Information
Details of FY 2023 Results
Consolidated income statement for the
full year 2023
(in €k) – IFRS
FY 2023
FY 2022
Change
€k
%
Product sales
6,218
7,479
-1,261
-17%
Licensing sales
4,262
-
+4,262
-
Total sales
10,480
7,479
+3,001
+40%
Other revenue
547
631
-84
-13%
Total revenue
11,027
8,111
+2,916
+36%
Cost of sales
(2,118)
(2,004)
-114
+6%
Research & Development expenses
(3,860)
(4,068)
+208
-5%
Sales & Marketing expenses
(5,618)
(5,800)
+182
-3%
General & Administrative expenses
(5,004)
(4,894)
-110
+2%
Share-based payments
(113)
(324)
+211
-65%
Current operating income (loss)
(5,686)
(8,983)
+3,297
-37%
Non-current operating income
6,918
(80)
+6,998
-
Operating income
1,231
(9,062)
+10,293
-
Share of equity affiliates
(2,528)
-
-2,528
-
Financial result
(1,956)
(2,118)
+162
-8%
Income taxes
(475)
-
-475
-
Other operating income/expenses
(464)
425
-889
-
Net profit
(3,727)
(11,180)
+7,453
-67%
Total sales Total Group sales amounted to €10.5m, up 42%
at constant exchange rates, driven by the strong volume growth of
the PPU business in the U.S. and the substantial contribution of
licensing sales.
With regard to license sales, the Group recognized over the year
$2.3m from the licensing agreement and $2.5m received as part of
the technology service fees.
Other revenue The other revenue amounted to €0.5m
corresponding to the research tax credit for the year.
Cost of goods sold Cost of sales came to €2.1m reflecting
a total gross margin of 66% over product sales excluding license
for the full year 2023 vs. 73% last year due in particular to the
placement of several systems in PPU accounts in the United States,
higher depreciation of low-rotation inventory and older-generation
systems, as well as to inflation in the production costs of certain
components.
Research and development expenses Research and
development costs were down by 5% over the period at €3.9m, with
the slight drop in R&D investments offsetting a rise in
personnel costs.
Sales and marketing expenses Sales and marketing expenses
were down by 3% over the period at €5.6m thanks to tight control
over marketing costs despite the increase in sales in the U.S.
General and administrative expenses General expenses were
slightly up by +2% over the period at €5.0m, impacted by the
reorganization of the finance team completed at the end of the
first half resulting in higher consulting fees.
Share-based payments The impact from share-based payments
was significantly lower than last year reflecting a large number of
cancellations of equity instruments following US-based employee
departures resulting from the strategic realignment.
Current Operating Income Current operating income
increased sharply by €3.3m to -€5,7m over the period thanks to the
sales increase and the reduction of operational costs.
Operating Income The Group's operating income was
positive at €1.2m, compared with a loss of -€9.1m in 2022,
favorably impacted by the recognition of exceptional income of
€6.9m over the period corresponding to the Group's gain on the
transfer of patents to the Tasly J.V.
Net Profit Net profit came to a loss of -€3.7m, compared
with a loss of -€11.2m in 2022.
Cash Flow from operating activities In 2023, cash flow
from operating activities amounted to -€0.7m, compared with -€8.8m
a year before, thanks to sales growth and payments associated with
the licensing agreement signed with Tasly Pharmaceutical.
Cash position as of December 31, 2023 Cash and cash
equivalents stood at €8.0m at December 31, 2023, up €4.8m on
December 31, 2022 notably thanks to the capital increase reserved
to Telix Pharmaceuticals.
Details of First Quarter 2024 Sales
The first quarter of 2024 was affected by a high basis of
comparison, due to the proceeds of $2.5 million received from Tasly
Pharmaceutical in 2023 resulting from with the technology fee
invoiced to the JV.
The PPU business, which accounts for 50% of sales in the United
States up 5 pts versus last year, is following the same favorable
trend initiated in 2023, with volumes up 47% year-on-year and 52%
in Ambulatory Surgical Centers (ASCs) only. The rise in volumes
offsets the negative price effect in Ambulatory Surgical Centers
(ASCs) linked to lower reimbursements from Medicaid & Medicare
(CMS) services.
This price cut decided by CMS is attributable to erroneous
procedure cost data reported by hospitals. The Company has been
working hard for several weeks in collaboration with experts and
end-user physicians to restore reimbursement to pre-existing levels
and is confident that a price adjustment will happen in the
foreseeable future.
In addition, several system sales were being finalized at the
end of the 1st quarter of 2024 and will therefore be booked in the
2nd quarter of 2024.
CMS reimbursement in the United States
In 2024, sales of PPU in the United States are expected to be
impacted by a reduction in reimbursement rates from the Centers for
Medicare and Medicaid Services (CMS), a consequence of changes in
the reimbursement calculation formula. Despite this setback, the
anticipated increase in sales volumes is projected to completely
counterbalance the effects of lower pricing.
This reimbursement adjustment stems from incorrect data
submissions by hospitals, and Mauna Kea is actively engaging with
CMS to rectify the calculation discrepancies. The Company is
cautiously optimistic that a price adjustment will happen in the
foreseeable future.
Quarterly Volume of PPU Procedures
Q1 2022
Q2 2022
Q3 2022
Q4 2022
Q1 2023
Q2 2023
Q3 2023
Q4 2023
Q1 2024
Volume of PPU procedures
678
686
613
589
693
1,013
899
1,361
1,017
The volume of PPU procedures continues the very positive trend
initiated in 2023, with the number of quarterly procedures
exceeding the significant threshold of 1,000 procedures per
quarter. It should be noted that the first quarter was impacted by
a one-off slowdown in the number of procedures following the
renegotiation of rates with the various medical centers in the
context of lower CMS reimbursements.
Fourth Quarter & Full Year 2023 Sales by Category
(in €k) – IFRS
Q1 2024
Q1 2023
Change
€k
%
Systems
70
387
-317
-82%
Consumables
870
662
+209
+32%
Services
216
318
-102
-32%
License fees
501
2,802
-2,301
-82%
Total sales
1,658
4,168
-2,510
-60%
In the first quarter of 2024, total sales amounted to €1.7m,
down 60% on the previous year, since in 2023 the Company had
received $2.5m from the JV as part of the technology transfer.
Consumables sales were up +32%, driven by continued growth in
the PPU business and probe sales. Despite a significant drop in the
price of PPU procedures due to lower CMS reimbursements, volume
growth fully offset the unfavorable impact of price on
revenues.
Sales of services were down over the quarter due to lower
invoicing to Johnson & Johnson for the CLEAR study, which is
now fully enrolled.
First Quarter 2024 & Full Year 2023 Sales by
Geography
(in €k) – IFRS
Q1 2024
Q1 2023
Change
€k
%
United States
754
851
-97
-11%
EMEA & ROW
349
468
-118
-25%
Asia Pacific
555
2,849
-2,295
-81%
Total sales
1,658
4,168
-2,510
-60%
In the United States, sales were down 11%, mainly due to the
delayed invoicing of a system that was under negotiation at the end
of the quarter. Excluding systems, sales in the region were up
5%.
In Europe, sales of systems were also being finalized at the end
of the first quarter, and will be booked in the second quarter.
As for sales in Asia-Pacific, the lower sales figure is due to
the exceptional income of $2.5m in respect of the technology
transfer to the JV with Tasly.
First Quarter 2024 Sales in Unit
Units (#)
Q1 2024
Q1 2023
Change
New systems sold*
1
3
-2
New systems placed**
3
5
-2
Total systems
4
8
-4
Consumables delivered
139
104
+35
* The change in the number of new systems sold over the period
may differ from that in reported sales, due to inventory
adjustments and product mix variation ** The reference date is the
contract signature date, which may differ from the system
installation date
***
Disclaimer This press release contains forward-looking
statements about Mauna Kea Technologies and its business. All
statements other than statements of historical fact included in
this press release, including, but not limited to, statements
regarding Mauna Kea Technologies' financial condition, business,
strategies, plans and objectives for future operations are
forward-looking statements. Mauna Kea Technologies believes that
these forward-looking statements are based on reasonable
assumptions. However, no assurance can be given that the
expectations expressed in these forward-looking statements will be
achieved. These forward-looking statements are subject to numerous
risks and uncertainties, including those described in Chapter 3 of
Mauna Kea Technologies' 2022 Universal Registration Document filed
with the Autorité des marchés financiers (AMF) on June 28, 2023
under number D-23-0545, which is available on the Company's website
(www.maunakeatech.fr), as well as the risks associated with changes
in economic conditions, financial markets and the markets in which
Mauna Kea Technologies operates. The forward-looking statements
contained in this press release are also subject to risks that are
unknown to Mauna Kea Technologies or that Mauna Kea Technologies
does not currently consider material. The occurrence of some or all
of these risks could cause the actual results, financial condition,
performance or achievements of Mauna Kea Technologies to differ
materially from those expressed in the forward-looking statements.
This press release and the information contained herein do not
constitute an offer to sell or subscribe for, or the solicitation
of an order to buy or subscribe for, shares of Mauna Kea
Technologies in any jurisdiction in which such offer, solicitation
or sale would be unlawful prior to registration or qualification
under the securities laws of any such jurisdiction. The
distribution of this press release may be restricted in certain
jurisdictions by local law. Persons into whose possession this
document comes are required to comply with all local regulations
applicable to this document.
____________________ 1 At current exchange rates 2 “Mauna Kea
Technologies Executed Agreement to Restructure of its Existing Loan
Agreement with the European Investment Bank”, on April 24, 2024
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240425876190/en/
Mauna Kea Technologies investors@maunakeatech.com
NewCap - Investor Relations Aurélie Manavarere / Thomas
Grojean +33 (0)1 44 71 94 94 maunakea@newcap.eu
Mauna Kea Technologies (EU:ALMKT)
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