- iCRO order backlog: €66.9m, an all-time high for Median, driven
by record order intake in Q4 2023.
- 2023 revenue: €22.2m, below 2022 revenue.
- Independent verification study for eyonis™ LCS (Lung Cancer
Screening): excellent results, achieving an AUC of 0.93, a value
significantly above the primary endpoint set at 0.80 in the pivotal
Standalone study.
- Company cash horizon: Q2 2025.
Fredrik Brag, CEO and Founder of Median
Technologies, will provide a Company update, outlining the 2024
strategic outlook and answering questions via webcast:
Thursday February 1, 2024 4:30 pm CET – 10:30 am ET:
webcast in English: sign-up link 6:00 pm CET – 12:00
pm ET: webcast in French: sign-up link
Regulatory News:
Median Technologies (FR0011049824, ALMDT, PEA/SME eligible)
announces its 2023 revenue, outlining both its strategic outlook
and key milestones for 2024.
Fredrik Brag, Chief Executive Officer and Founder of Median
Technologies, commented: "In Q4 2023, our iCRO1 business achieved
record-high order intake, which increased significantly our
backlog. The order backlog2 is at an all-time high of €66.9m. Today
more than ever, the pharmaceutical industry is investing massively
in Artificial Intelligence (AI), specifically in the field of
oncology clinical trials, and our differentiated Imaging Lab
solution enables us to win business with Big Pharma groups, partner
with global CROs and widen the scope of indications that our
services address. We expect to return to growth in 2024 on the back
of a decline in 2023 revenue due to soft order intake in China
caused by the Covid lockdowns in 2022 and H1 2023."
Fredrik Brag added: “Execution of the pivotal studies for
eyonis™ LCS is on track following the excellent results from the
independent verification study announced in January 2024. Studies
part of the FDA 510(k) clearance and CE marking process were
launched in July last year, all patients have been recruited, the
independent verification is already finalized and the Standalone
and MRMC studies are underway. The Standalone study will be
finalized in Q2 2024 and the MRMC study in Q3 2024. We are
targeting FDA 510(k) clearance for the CADe/CADx Software as
Medical Device eyonis™ LCS in Q1 2025, followed by the launch for
the US lung cancer screening market, which covers 14.5 million
people with an existing reimbursement per procedure of $650.
Regarding Europe, we expect to obtain CE marking in Q2 2025. Lung
cancer is the number one cause of mortality by cancer worldwide.
Early diagnosis has been proven to save patients’ lives. Our
AI-powered imaging solutions will deliver major progress in the
early diagnosis of lung cancer."
Jean-Christophe Montigny, Chief Financial Officer of Median
Technologies commented: "With our successful refinancing which took
place in July 2023, plus the €8.5m drawdown at the start of 2024
for the final tranche of the loan granted by the European
Investment Bank (EIB), we expect Company’s operations to be fully
financed until Q2 2025".
eyonis™:
AI-driven patient care innovation
Excellent results from eyonis™ LCS independent verification
study
In July 2023, the Company announced the initiation of all US and
European sites involved in the pivotal eyonis™ LCS (Lung Cancer
Screening) studies, the results of which will be the subject of
regulatory filings for FDA 510(k) and CE marking. All patients have
been recruited, the independent verification is already finalized
and the Standalone and MRMC studies are underway.
In the second half of 2023, the Company conducted an independent
verification study on a version of the SaMD eyonis™ LCS,
incorporating an algorithm developed in H2 2023. The tested
software achieved excellent results, with an area under the curve
(AUC) value of 0.93 at patient level versus an AUC of 0.80 – the
minimum value set as a primary endpoint in the Standalone study.
Results from the independent verification studies were released in
January 2024.
Initial results for eyonis™ HCC detection AI model presented at
ESMO 2023
Designed to detect hepatocellular carcinoma (HCC) lesions as
small as 10 mm in diameter, Median’s eyonis™ HCC AI model showcased
promising results, achieving a sensitivity rate of 92% on the test
data set. This notable achievement significantly outperformed the
average sensitivity rate of 69% observed among radiologists without
AI and Machine Learning (ML) computer-aided detection software.
Results based on the PHELICAR clinical data registry (AP-HP
Hospital, Paris, France) were presented at the ESMO annual
conference in October 2023.
2024 strategic outlook and key milestones
- eyonis™ LCS Standalone study (MT-LCS-002, REALITY): release of
topline study results in Q2 2024,
- eyonis™ LCS Multi-Reader Multi-Case study (MRMC, MT-LCS-004,
RELIVE): release of topline study results in Q3 2024,
- CADe/CADx SaMD eyonis™ LCS filing (FDA 510(k)): Q4 2024, FDA
510(k) clearance expected Q1 2025,
- CADe/CADx SaMD eyonis™ LCS filing (CE marking): Q4 2024, CE
marking expected Q2 2025,
- eyonis™ LCS distribution partnership agreements with
global-leading players: Q4 2024,
- Launch of Health economics studies, to support reimbursement
code negotiation with payers: Q4 2024,
- Strategic partnerships with leading pharmaceutical groups and
global diagnostics companies.
iCRO: AI-driven drug development and
therapeutic innovations
Order backlog at all-time high of €66.9m, driven by record order
intake in Q4 2023; full-year 2023 revenue: €22.2m
On December 31, 2023, the order backlog stood at €66.9m, up a
substantial €4.2m versus September 30, 2023 (+7%) and €6.1m
year-on-year (+10%). As such, the Company's order backlog is at an
all-time high.
Q4 2023 revenue totaled €5.3m, above the €5.1m generated in the
same period in 2022. Revenue stemmed entirely from Median's iCRO
Business Unit, which provides imaging solutions and services to
measure drug efficacy in oncology clinical trials. As previously
stated by the Company, full-year 2023 revenue was impacted by
sluggish order intake in China during H2 2022 and H1 2023, totaling
€22.2m, i.e., a year-on-year decline of 6.7% (FY 2022 revenue:
€23.7m).
2024 strategic outlook and key milestones
- Scale up the iCRO core business, with double digit growth
propelled by a recovery in China and an acceleration in US
business.
- Accelerate momentum from Imaging Lab, iCRO’s unique and highly
differentiated AI-powered Imaging solution: – Preferred provider
status among Big Pharma groups, – Partnership agreements with
leading pharmaceutical corporations, – New partnerships with global
CROs.
Cash of €19.5m on December 31, 2023,
strengthened in January 2024
On December 31, 2023, cash and cash equivalents stood at €19.5m,
versus €21.5m a year prior. In July 2023, the cash position was
strengthened 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 with a
conversion price of €6.458.
On January 4, 2024, the Company's cash position was also
increased with the receipt of €8.5m for the release of the final
tranche of the loan granted by the European Investment Bank (EIB)
in December 2019.
Next financial release on April 25, 2024, after
the market close: 2023 Financial Report
Disclaimer: The preliminary figures set forth above are based on
management’s initial review of the Company’s operations for the
period ending December 31st, 2023, and are subject to revision
based upon the finalization of the review conducted on the full
year financial statements by the Group's statutory auditors. Actual
results may differ materially from these preliminary figures as a
result of the completion of annual closing procedures, final
adjustments and other developments arising between now and the time
that the Company’s financial results are finalized, and such
changes could be material. In addition, these preliminary figures
are not a comprehensive statement of the Company’s financial
results for 2023, should not be viewed as a substitute for
condensed interim financial statements prepared in accordance with
generally accepted accounting principles, and are not necessarily
indicative of the Company’s results for any future period.
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,
any future litigation in this area and the outcome of such
litigation, changes in foreign exchange rates and interest rates,
volatility in economic conditions the impact of cost containment
initiatives and changes of the same, the average number of shares
outstanding, as well as those developed or identified in the
documents available on the Median Technologies' website and in
particular the “Specific Risk Factors” section of the financial
annual report for the year ended December 31, 2022, published on
April 20, 2023. 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 French 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 and metabolic disease
diagnoses and 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. Since its
inception, the French-based company, with a presence in the U.S.
and China, has been recognized as an "Innovative company" by BPI
France and trades 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 iCRO: 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 canceled contracts, and currency impact for projects in foreign
currency (re-valued at the exchange rate on closing date). Orders
are booked once the customer confirms its retention of the
Company’s services for a given project in writing. The contract is
usually signed in the months that follow a written
confirmation.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240129539472/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 ggasparetto@actifin.fr
Median Technologies (EU:ALMDT)
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