- Q1 2024 revenue at €5.4 million as of March 31, 2024, with
growth expected for the remainder of 2024.
- Order backlog as of March 31, 2024: €68.2 million, an increase
in backlog as of December 31, 2023 (€66.8 million), the highest
order backlog ever.
- Cash position as of March 31, 2024: €20.9 million, financial
horizon through to Q2 2025.
Regulatory News:
Median Technologies (FR0011049824, ALMDT, PEA-PME scheme
eligible, “Median” or the “Company”) today reported its 2023
consolidated annual financial results, as of December 31, 2023, and
provided financial information (unaudited) for the first quarter of
2024, as of March 31, 2024. The consolidated financial statements
for the financial year ended December 31, 2023, were audited and
approved by the Company’s Board of Directors on April 24, 2024.
Fredrik Brag, Chief Executive Officer and Founder of Median
Technologies said: “In 2024, we expect strong growth in our
backlog in the USA and in Europe and a return to normal in China,
driven by successful recent collaborations with global CROs as well
as significant traction with leading pharmaceutical companies. A
major trend in the pharmaceutical industry is the wide-scale impact
expected from AI (Artificial Intelligence). Our AI-powered Imaging
Lab offering is a key differentiator and a robust growth driver. We
are in advanced discussions with global-leading pharmaceutical
companies to implement our proprietary AI-powered solutions in
oncology drug development. Imaging Lab’s AI technologies will
enable pharmaceutical companies to develop personalized treatments,
delivering better patient outcomes. In Quarter 1, our revenues were
impacted by the postponement to Quarter 2 of some studies due to
late patient recruitment. We expect to recoup most of the delay in
the coming quarters to resume revenue growth for the iCRO (imaging
Contract Research Organization) business unit in 2024.”
Fredrik Brag added: “In 2024, eyonis™ activity
will focus on the pivotal clinical studies of our SaMD eyonis™ Lung
Cancer Screening (LCS) CADe/CADx as well as partnering with major
strategic players to enable market access. We expect to obtain both
510(k) FDA clearance and CE marking for eyonis™ LCS in 2025. In
early 2024, we announced the preliminary results from the
independent eyonis™ LCS verification study Run 1. The results
showed that eyonis™ LCS could have one of the strongest impacts
ever on lung cancer care by identifying cancers at an early stage
when they can be cured. The verification study achieved excellent
results, with an area under the curve (AUC) value of 0.93 at the
patient level. These results are substantially higher than the
primary endpoint’s acceptance value discussed with the FDA for the
Standalone study which is an AUC of 0.80. Our Standalone and MRMC
clinical studies will continue throughout the year. Furthermore,
health-economic studies will be conducted in the second half of
2024 to secure reimbursements for eyonis™ LCS, initially in the
United States”.
First-quarter 2024 financial information (unaudited)
As of March 31, 2024, Median's quarterly revenue was €5.4
million, comparable to Q1 2023 revenue. Median's revenue is
achieved entirely by the iCRO1 business, which delivers services to
the global biopharmaceutical industry for image management in
oncology clinical trials.
The order backlog2 stood at €68.2 million as of March 31, 2024,
an increase from December 31, 2023 (€66.8 million). The Company’s
order backlog is at an all-time high.
As of March 31, 2024, the Company’s cash position was €20.9
million. On January 4, 2024, the Company’s cash position increased
with the €8.5 million drawdown of the final tranche of the loan
granted by the European Investment Bank (EIB) in December 2019.
Historically, the first quarter is characterized by higher external
and internal expenses, which generate significant cash outflows for
the period. Cash consumption over this period is not indicative of
quarterly cash consumption averaged over the year.
The Company considers that it is positioned to meet the
financing needs of operations until Q2 2025.
As a reminder, on July 3, 2023, Median signed a Securities
Purchase Agreement with Celestial Successor Fund, LP (“CSF”), a
long-lasting partner and its second biggest shareholder (7% of
outstanding shares). Consequently, and concurrently with a capital
increase of €11.6 million, on July 19, 2023, CSF subscribed to €10
million in convertible bonds issued by Median, with a maturity of
seven (7) years, and a fixed conversion price of €6.458.
Following conversations on the interpretation of the Securities
Purchase Agreement, CSF and Median have agreed to adjust the
conversion price of the bonds to €5.00. Consistent with the
long-lasting partnership between CSF and Median, this agreement
strengthens the future relationship between CSF and Median.
2023 Financial Highlights
Consolidated statement of cash
flows
Cash flow (€k)
12/31/2023
(12 months)
12/31/2022
(12 months)
Operating cash flow
(19,160)
(14,206)
Change in operating working capital
(660)
(955)
Net cash flow from operating
activities
(20,236)
(15,793)
Net cash flow from investing
activities
(1,253)
(1,387)
Net cash flow from financing
activities
19,722
(277)
Impact of changes in exchange rates
(203)
(80)
Net change in cash and cash
equivalents
(1,971)
(17,538)
Cash and cash equivalents at end of the
period
19,495
21,467
- Net cash flow consumption from operating activities increased
from (€15.8) million in 2022 to (€20.2) million in 2023. This
increase was mainly driven by lower sales of iCRO, investments
related to Median’s Software as Medical Device (SaMD) eyonis™ LCS,
and additional IT resources.
- Cash and cash equivalents at end of period (end-2023) totaled
€19.5 million, compared to €21.5 million at end-2022. The Company’s
cash position was bolstered in July 2023, with refinancing of
€21.6m, comprising a capital increase of €11.6m with a subscription
price of €4.70 per share, and the issue of €10m in fixed-rate
convertible bonds. The Cash position was further strengthened in
early January 2024 with the drawdown of a €8.5m tranche of the 2019
EIB loan.
Net income statement under IFRS accounting
rules
Net profit (loss) (€k)
12/31/2023
(12 months)
12/31/2022
(12 months)
Revenue
22,226
23,670
Income from ordinary activities
22,780
23,945
Staff costs
(25,485)
(28,061)
External expenses
(19,657)
(18,846)
Operating profit (loss)
(23,116)
(23,356)
Net financial income
211
3,664
Net profit (loss)
(22,982)
(20,213)
- 2023 net loss reached €23.0 million i.e., a €2.8 million
increase on the 2022 net loss.
- Full-year 2023 revenue was impacted by slow order intake in
China during H2 2022 and H1 2023, for a total of €22.2m, i.e., a
year-on-year decline of 6.7% (full-year 2022 revenue: €23.7m).
- Operating loss amounted to €23.1 million, comparable to the
Company’s 2022 operating loss.
- External expenses were up by €0.9 million, an increase driven
by new investments in IT services and fees related to technology
infrastructure, primarily for eyonis™.
- Staff costs were down €2.6 million, compared to 2022 staff
costs, mainly due to the decrease in share-based payments from
€7.9m in 2022 versus €2.8m in 2023. Actual payroll costs increased
by 12%, consistent with the increase in personnel, up to an average
of 241 people in 2023.
2023 operating highlights
eyonis™ - AI-driven patient care
innovation: in 2023, the Company made significant strides
regarding its eyonis® portfolio development and launched the SaMD
eyonis™ Lung Cancer Screening (LCS) pivotal clinical plan, a key
milestone in Median’s roadmap to obtain marketing authorizations
for the US and Europe markets. All US and European clinical sites
involved in the SaMD eyonis™ LCS pivotal clinical plan were
initiated in July 2023.
In the second half of 2023, the Company performed an independent
verification study on a version of the SaMD eyonis™ LCS,
incorporating an algorithm developed in H2 2023. The tested SaMD
achieved excellent verification results, with an area under the
curve (AUC) value of 0.93 at patient level versus an AUC of 0.80 –
the acceptance value of the primary endpoint in the Standalone
study. Topline preliminary results of the independent verification
studies were issued in January 2024.
Regarding the SaMD eyonis™ HCC (Hepatocellular Carcinoma),
initial results for Median’s eyonis™ HCC AI model based on the
PHELICAR clinical data registry (AP-HP Hospital, Paris, France)
were presented at the European Society of Medical Oncology (ESMO)
annual congress held October 2023, in Barcelona (Spain). Designed
to detect hepatocellular carcinoma (HCC) lesions as small as 10 mm
(0.4 in”) in diameter, the HCC AI model showcased promising
results, achieving a sensitivity rate of 92% on the set test data.
This notable achievement significantly outperformed the average
sensitivity rate of 69% observed among radiologists without AI and
Machine Learning (ML) computer-aided detection software.
iCRO – AI-driven drug development and
therapeutic innovation: in Q3
2023, Median’s iCRO business was successfully inspected by the US
Food and Drug Administration (FDA) and the Chinese National Medical
Products Administration (NMPA) for a phase I/II oncology study with
one of the global-leading pharma companies. To date, the Company
has been successfully inspected 4 times by the FDA, and 13 times by
the Chinese NMPA, continuing its best-in-class track record.
As of December 31, 2023, Median had supported 249 oncology
studies, including 93 Phase III studies. Phase III studies
represent the fastest growing segment for Median’s iCRO business.
In Q3 and Q4 2023, iCRO business accelerated in China, with a
robust ramp-up in new requests for proposals and contracts, on the
back of a declining order intake during the first half of 2023 and
in 2022 on a full-year basis.
Imaging Lab, Median's AI-powered imaging offering for drug
development, continued to attract strong interest from
biotechnology and pharmaceutical companies, particularly large
corporations based in the United States. AI supports the
development of precision medicine in oncology and Imaging Lab is
Median’s most prominent technology asset to ramp up iCRO business,
creating a unique point of differentiation compared to imaging
vendors providing only classical imaging readouts.
Median Technologies informs its shareholders
and the financial community that its annual financial report on the
accounts for the year ended December 31, 2023, has been made
available and filed with the French financial market authority
(Autorité des Marchés Financiers). The annual financial report is
available on the Company’s website:
https://mediantechnologies.com/investors/financial-results-and-reports/
Forward-looking statements: This press release contains
forward-looking statements. These statements are not historical
facts. They include projections and estimates as well as the
assumptions on which these are based, statements concerning
projects, objectives, intentions, and expectations with respect to
future financial results, events, operations, services, product
development and potential, or future performance. These
forward-looking statements can often be identified by the words
"expects," "anticipates," "believes," "intends," "estimates" or
"plans" and similar expressions. Although Median's management
believes that these forward-looking statements are reasonable,
investors are cautioned that forward-looking statements are subject
to numerous risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Median Technologies,
that could cause actual results and events to differ materially
from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and
uncertainties include, but are not limited to, the uncertainties
inherent in research and development, future clinical data and
analysis, and decisions by regulatory authorities. Median
Technologies' ability to take advantage of external growth
opportunities and to complete related transactions and/or obtain
regulatory approvals, risks associated with intellectual property,
changes in foreign exchange rates and interest rates, volatility in
economic conditions the impact of cost containment initiatives and
their evolution, the average number of shares outstanding, as well
as those developed or identified in Median Technologies' public
filings with the AMF, including those listed under "Risk Factors"
and "Forward-Looking Statements" in Median Technologies' 2023 FY
report providing financial results as of December 31, 2023 and
released on April 25, 2024. Median Technologies does not undertake
to update any forward-looking information or statements, subject to
applicable regulations, in particular Articles 223-1 et seq. of the
General Regulation of the Autorité des Marchés Financiers.
About Median Technologies: Pioneering in innovative imaging
solutions and services, Median Technologies harnesses cutting-edge
AI to elevate the accuracy of early cancer diagnoses and cancer
treatments. Median's offerings, including iCRO for medical image
analysis and management in oncology trials and eyonis™, AI/ML
tech-based suite of software as medical devices (SaMD), empower
biopharmaceutical entities and clinicians to advance patient care
and expedite novel therapies. The French-based company, with a
presence in the U.S. and China, is listed on the Euronext Growth
market (ISIN: FR0011049824, ticker: ALMDT). Median is eligible for
the French SME equity savings plan scheme (PEA-PME). For more
information: www.mediantechnologies.com
1 Imaging Contract Research Organization 2 The order backlog is
the sum of orders received but not yet fulfilled. An increase or
decrease in the order backlog corresponds to the order intake of
the reporting period, net of invoiced services, completed or
cancelled contracts, and currency impact for projects in foreign
currency (re-evaluated at the exchange rate on closing date).
Orders are booked once the customer confirms, in writing, its
retention of the Company’s services for a given project. The
contract is usually signed a few months after written
confirmation.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240425540320/en/
Median Technologies Emmanuelle Leygues Head of Corporate
Marketing & Financial Communications +33 6 10 93 58 88
emmanuelle.leygues@mediantechnologies.com
Press - ALIZE RP Caroline Carmagnol +33 6 64 18 99 59
median@alizerp.com
Investors - ACTIFIN Ghislaine Gasparetto +33 6 21 10 49
24 ghislaine.gasparetto@seitosei-actifin.com
Grafico Azioni Median Technologies (EU:ALMDT)
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Da Nov 2024 a Dic 2024
Grafico Azioni Median Technologies (EU:ALMDT)
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