- H2 2024 revenue €12.0 million up 10.2% compared to H2 2023
- FY 2024 revenue €22.9 million up 3.3% compared to 2023
- Growing order backlog at €71.0 million, as of December 31,
2024
- eyonis™ Lung Cancer Screening (LCS) regulatory filings for FDA
510(k) clearance and CE marking in Q2, 2025
- eyonis™ LCS FDA 510(k) clearance expected in Q3, 2025 followed
by commercial launch in the USA
- EIB 2020 loan maturity extension combined with the new
financing agreement with Iris, and operational improvements in the
iCRO Business Unit organization, extend the Company’s cash runway
into Q4 2025
Regulatory News:
Median Technologies (FR0011049824, ALMDT, PEA/SME scheme
eligible), a leading developer of eyonis™, a suite of artificial
intelligence (AI) powered Software as a Medical Device (SaMD) for
early cancer diagnostics, and a globally leading provider of
AI-based image analyses and imaging services for oncology drug
developers, releases today its 2024 key financial indicators
(unaudited), and provides an outlook on the Company’s critical
milestones in 2025.
Fredrik Brag, Chief Executive Officer and Founder of Median
Technologies, commented: "We are delighted to report that the
second half of 2024 saw an acceleration of our iCRO1 business unit
revenue growth, +10.2% compared to revenues over the same period a
year before. We are now back to growth, after lower-than-expected
revenues in 2023 and H1 2024. Our new major iCRO agreements with
Top 3 and Top 10 pharma groups, the extension of our footprint in
South Korea and Japan and new Master Services Agreements with
global CROs in 2024 are driving continued order backlog growth in
2025. Thanks also to significant ongoing operational improvements
in the iCRO Business Unit organization, we anticipate iCRO will
improve its profitability in 2025 and contribute to the financing
of Median.
2025 is a truly pivotal year, expected to end with the
commercialization of our first AI-based Software as a Medical
Device, eyonis™ Lung Cancer Screening (LCS); we expect to file FDA
510(k) clearance and CE marking in Q2 2025, and obtain FDA
marketing authorization in Q3. This will be followed by immediate
commercialization in the U.S.
Lung cancer represents the number one cancer mortality
worldwide, because it is very often diagnosed at a late stage.
Early lung cancer diagnosis through screening procedures has
clearly been proven to save patients’ lives. We are confident that
eyonis™ LCS will deliver greater accuracy and efficiency to
increase early diagnosis and support radiologists in navigating
complex and often inconclusive imaging data, saving lives and
avoiding astronomical medical costs in the process. We believe
there is an ethical and economic imperative to roll out AI enabled
lung cancer screening to all those who can benefit."
eyonis™LCS
Software as a Medical Device: AI-driven innovation for Lung Cancer
Screening
2024 key achievements
Median reported in August that eyonis™ LCS, met all primary and
secondary endpoints with statistical significance in REALITY
(Clinicaltrials.gov identifier: NCT06576232), the first of the two
pivotal studies for Median’s fully owned Software as a Medical
Device eyonis™ LCS, providing an analytical validation.
A webinar on the REALITY data held in November 2024, featured
two globally leading U.S. pulmonologists discussing how eyonis™ LCS
will be used to help people at risk of lung cancer.
2025 strategic outlook and key milestones
The Company is on track to communicate the second eyonis™ LCS
pivotal study, RELIVE (Clinicaltrials.gov identifier: NCT06751576),
in the coming weeks. RELIVE is a Multi-Reader Multi-Case (MRMC)
trial that will offer clinical validation of eyonis™ LCS to
complement the analytical validation already achieved with REALITY.
The RELIVE study objective is to compare the ability of
radiologists to successfully diagnose lung cancer in patients with
or without the help of eyonis™ LCS.
Regulatory filings for U.S. FDA 510(k) clearance and for CE
marking, will be submitted in Q2 2025 for eyonis™ LCS. Marketing
authorizations are expected in Q3 2025 and Q1 2026, for U.S. and
EEA, respectively, assuming normal regulators’ review times.
Working in parallel, Median is in active discussions with
several leading U.S. AI diagnostic commercialization organizations
for eyonis™ LCS. The Company will review in due course its best
possible partnering options for the commercialization of eyonis™
LCS.
iCRO: AI-driven and central imaging
services for oncology drug development
2024 key financial indicators
Median’s 2024 revenue stemmed entirely from the iCRO Business
Unit, which provides imaging services to measure drug efficacy in
industry-sponsored oncology trials.
Q4 2024 revenue totaled €5.9 million, up 8.3%, vs €5.4 million
revenue generated over the same period in 2023.
H2 2024 saw 10.2% growth, with revenues totaling €12.0 million,
compared to €10.9 million revenues over the same period the prior
year.
2024 Full-Year revenue stood at €22.9 million, a 3.3% increase
compared to €22.2 million 2023 FY revenue.
Revenue growth acceleration over the second half of 2024
confirms the expected recovery of revenue.
On December 31, 2024, the order backlog2 stood at €71.0 million,
vs €68.2 million as of September 30, 2024, and vs €66.9 million as
of December 31, 2023.
2025 strategic outlook
Median Technologies’ iCRO Business Unit is currently the
preferred provider for two of the top three global pharma companies
in oncology, with the largest pipelines of oncology studies in the
world. In 2025, the Company will continue to deploy a 3-pillar
strategy to drive the iCRO business growth: becoming the preferred
imaging services provider for additional leading oncology groups;
strengthening partnerships with global CROs3; and geographical
expansion in new fast growing clinical trial markets, notably East
Asia.
Importantly, the iCRO Business Unit has launched this strategy,
thanks not only to its central imaging services but also Imaging
Lab, an entity of iCRO that provides biopharma companies with
advanced AI-based decision-making capabilities. Imaging Lab AI
image analysis capabilities are a powerful catalyst in the sales
process, differentiating and increasing the attractiveness of iCRO
services because it offers unique added value compared to peers in
the image processing space. Median aims in 2025 to establish new
master services agreements with flagship biopharmaceutical
companies, such as the one announced in August 2024.
Over the second half of 2024, the Company implemented
significant operational improvements to enhance the profitability
of the iCRO business. This effort will continue in 2025.
Cash and cash equivalents at €8.1m on
December 31, 2024
On December 31, 2024, cash and cash equivalents stood at €8.1
million, versus €19.5 million a year prior. Early 2024, the
Company’s cash position was strengthened with the receipt of €8.5
million from the release of the final tranche of the 2020 loan
granted by the European Investment Bank (EIB).
Cash position strengthened in January
2025, extending the Company’s cash runway from Q2 to Q4
2025
On January 24, 2025, the Company announced that the EIB had
agreed to extend the maturity of the 2020 loan granted to Median,
from April to October 2025. Median Technologies and the European
Investment Bank have also agreed on a new loan facility for up to
€37.5 million, with the release of tranches subject to certain
milestones. Description of the new financing project, which is
currently under appraisal is available on the EIB website. The
legal documentations for the 2025 loan and the 2020 loan maturity
extension are in process and expected to be finalized in Q1
2025.
On the same date, Median Technologies also announced that on
January 23, 2025, the Company signed a financing agreement with
Iris in the form of bonds redeemable in shares for a maximum amount
of €10 million, with an initial tranche of €4 million. The Company
will have the right to suspend and reactivate the drawdowns of the
tranches without penalty. The key terms and conditions of the
financing facility are as follows:
- A single tranche of 4,000 warrants,
subscribed by Iris Capital, each warrant entitling its holder to
subscribe to a bond redeemable in shares, - Iris Capital has
committed to subscribing over a 24-month period to 4,000 bonds upon
the exercise of the warrants in six tranches (the first for
€4,000,000, the second for €2,500,000, the third to fifth for
€1,000,000 each, and the sixth and final for €500,000), - Median
Technologies will have the right to suspend and reactivate the
drawdowns of the tranches without penalty, - The redemption price
of the bonds in new shares is equal to 95% of the lowest
volume-weighted average price over the twenty-five (25) trading
days immediately preceding the bond redemption date. By way of
exception, the parties may agree on a redemption price for the
Bonds in the event of a block sale of the shares resulting from the
redemption of the said Bonds by Iris Capital. - Furthermore, it is
specified that the redemption price of the bonds can in no case be
lower than (i) the minimum price set by the board of directors of
Median Technologies, namely 95% of the volume-weighted average
price of the trading day immediately preceding the bond redemption
date, (ii) the minimum price set by the combined general meeting of
the company's shareholders on June 19, 2024, namely the average
closing price of Median Technologies’ ordinary shares observed over
the twenty (20) trading sessions preceding the bond redemption
date, reduced by a discount of 20%, (iii) nor the nominal value of
the company’s shares.
The new financing agreement with Iris, the extension of the
EIB’s 2020 loan maturity from April to October 2025 combined with
the implementation of iCRO operational improvements extend the
Company’s cash runway into Q4, 2025. Successful completion of
milestones enabling drawdowns of the new 2025 EIB loan tranches
would extend the Company’s cash runway beyond Q4, 2025.
Next financial release on April 29, 2025, after
the market close: 2024 Financial Report
About Median Technologies: Pioneering innovative imaging
services and Software as a Medical Device, Median Technologies
harnesses cutting-edge AI to enhance the accuracy of early cancer
diagnoses and cancer treatments. Median's offerings include iCRO,
which provides medical image analysis and management in oncology
trials, and eyonis™, an AI/ML tech-based suite of software as a
medical device (SaMD). Median empowers biopharmaceutical entities
and clinicians to advance patient care and expedite the development
of novel therapies. The French-based company, with a presence in
the U.S. and China, trades on the Euronext Growth market (ISIN:
FR0011049824, ticker: ALMDT). Median is also eligible for the
French SME equity savings plan scheme (PEA-PME). For more
information, visit www.mediantechnologies.com.
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 any other 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, including the risks set forth in the annual financial
report of the Company published on April 25, 2024, which is
available on the Company's website
(https://mediantechnologies.com/). The occurrence of all or parts
of such risks could cause actual results and events to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements.
All forward-looking statements in this press release are based
on information available to Median Technologies as of the date of
the press release. 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.
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, 2024, 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 2024, should not be viewed as a substitute for
financial statements prepared in accordance with generally accepted
accounting principles, and are not necessarily indicative of the
Company’s results for any future period.
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 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.
3 CRO: Contract Research Organization
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250130321829/en/
MEDIAN TECHNOLOGIES Emmanuelle Leygues VP, Corporate
Marketing & Financial Communications +33 6 10 93 58 88
emmanuelle.leygues@mediantechnologies.com
Investors Ghislaine Gasparetto SEITOSEI ACTIFIN
+33 6 21 10 49 24 ghislaine.gasparetto@seitosei-actifin.com
U.S. media & investors Chris Maggos COHESION
BUREAU +41 79 367 6254 chris.maggos@cohesionbureau.com
Press Caroline Carmagnol ALIZE RP +33 6 64 18 99
59 median@alize.com
Median Technologies (EU:ALMDT)
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