- Further double-digit growth for the Company in 2022: revenue up
16% compared with 2021 (€23.7 million vs. €20.5 million).
- Revenue of €5.6 million and order backlog at €62 million in Q1
2023.
- Cash and cash equivalents of €13.1 million at March 31,
2023.
- Company financing horizon confirmed for December 2023.
- Advanced discussions with long-standing shareholders and
financial partners to invest in the further growth of the
Company.
- Continued improvement of iBiopsy® and confirmed launch of
pivotal studies in Q2 2023 for marketing authorization on the US
market expected in H1 2024.
Regulatory News:
Median Technologies (Euronext Growth - ALMDT) (Paris;ALMDT)
whose Board of Directors met on April 19, 2023 to approve the
consolidated financial statements for the financial year ending
December 31, 2022, today announces its full-year results for 2022
and business indicators (unaudited) for the first quarter of
2023.
"Median Technologies continued its double-digit growth in 2022.
In the first quarter of 2023, we achieved revenue of €5.6 million,
with an order backlog of €62 million at March 31. The Company's
financing horizon is confirmed for December 2023. Advanced
discussions are underway with our long-standing shareholders,
coupled with new investors. Our goal is to secure Median's cash
position for approximately 24 months.", commented Fredrik Brag, CEO
and founder of Median Technologies. "AI is in the process of
revolutionizing early diagnosis and the treatment of cancer
patients. iBiopsy® is positioned to address major health and
survival issues with lung cancer and liver cancer among the most
deadly. iCRO's unique positioning with Imaging Lab will foster
strategic partnerships with leading pharmaceutical and AI companies
to optimize new molecule development plans as well as the
development of companion tests by leveraging AI technologies.",
added Fredrik Brag.
Key figures and significant events of Q1 2023
At March 31, 2023, Median's quarterly revenue was €5.6 million,
in the context of gradual sales recovery in China, where the zero
Covid policy of 2022 had penalized order intake in previous
quarters. Revenue for Q1 2023 was up 9.8% on revenue of Q4 2022.
Median's revenue is generated 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 €62 million on March 31, 2023, up
slightly relative to December 31, 2022 (€60.8 million). The
quarterly order backlog was propelled by the projects awarded and
contracts secured, primarily in the United States and Europe, in
parallel to the gradual recovery in China, which is expected to
increase in the quarters ahead.
Concerning iBiopsy®, in February 2023, Median Technologies
announced the completion of the Q-submission phase – initiated in
May 2022 – with the United States Food and Drug Administration
(FDA). This phase seeks to clarify and implement the FDA's
expectations on key topics including pivotal study protocols for
the iBiopsy® Lung Cancer Screening (LCS) CADe/CADx3 Software as
Medical Device (SaMD). These protocols are now complete, and the
Company is ready for the launch of the iBiopsy® LCS CADe/CADx SaMD
pivotal studies expected in Q2 2023.
In March 2023, Median Technologies presented new results for the
performance of its iBiopsy® LCS CADe/CADx SaMD. Obtained from a
cohort of 9,863 patients, these new results were presented at the
European Congress of Radiology (ECR) and, compared to the results
reported in 2022, they demonstrated a considerably improved
performance with a sensitivity of 96.5% for a specificity of 97.2%
on end-to-end lung nodule detection and malignancy
characterization.
Median aims to obtain 510(k) clearance from the FDA in H1 2024
for the iBiopsy® LCS CADe/CADx SaMD.
On March 31, 2023, cash and cash equivalents totaled €13.1
million. Historically, first-quarter performance 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 December 2023. The Company has
entered into advanced discussions with long-standing shareholders
and financial partners in order to be able to finance operations
further out from this period. Moreover, under certain conditions,
the Company could exercise the second tranche of financing from the
European Investment Bank (EIB) for an additional amount of €10
million.
Full-year 2022 results: continued growth for iCRO business
and investments for iBiopsy® software as medical devices
(SaMD)
On January 19, 2023, Median reported business indicators for
2022 and now confirms the following audited figures:
- Revenue at December 31, 2022 of €23.7 million;
- An order backlog at December 31, 2022 of €60.8 million;
- Cash and cash equivalents of €21.5 million at December 31,
2022.
In addition to the standard iCRO solution that generates the
Company's entire revenue, the Imaging Lab clinical trials
Artificial Intelligence (AI) offering was launched at the 2022
American Society of Clinical Oncology (ASCO) International
Conference in Chicago. Imaging Lab provides new answers in a number
of strategic areas that determine the success of clinical trials ,
unlocking AI to include patients with early-stage diseases in the
trials as well as discovering predictive biomarkers of response to
drug candidates. Its purpose is to optimize the clinical
development plan for new molecules to boost the success rate of
clinical trials.
Regarding iBiopsy®, for 2022, Median posted an excellent
performance of its proprietary algorithms in sensitivity and
specificity on end-to-end lung nodule detection and malignancy
characterization using its SaMD, which harnesses AI and machine
learning technologies. This innovation paves the way for early
diagnosis of lung cancer, providing new opportunities to implement
lung cancer screening programs. In 2022, progress was reported for
development programs targeting liver cancer, non-alcoholic fatty
liver disease/non-alcoholic steato hepatitis (NAFLD/NASH) and
incidental lung cancer diagnoses.
Financial information at December 31, 2022 (consolidated
financial statements under IFRS accounting rules)
Consolidated statement of cash
flows
Cash flow (€k)
12/31/2022
12/31/2021
(12 months)
(12 months)
Operating cash flow
(14,206)
(8,325)
Change in operating working capital
requirement
(955)
(1,372)
Net cash flow from operating
activities
(15,793)
(10,127)
Net cash flow from investing
activities
(1,387)
(671)
Net cash flow from financing
activities
(277)
33,203
Impact of changes in exchange rates
(80)
289
Net change in cash and cash
equivalents
(17,538)
22,694
Cash and cash equivalents at end of the
period
21,467
39,006
Net cash flow consumption from operating activities increased
from (€10.1) million in 2021 to (€15.8) million in 2022, due to
investments to develop the iBiopsy® SaMD, and partly due to the
increase in working capital requirements driven by higher
sales.
Net income statement under IFRS accounting
rules
Net profit (loss) (€k)
12/31/2022
(12 months)
12/31/2021
(12 months)
Revenue
23,670
20,547
Income from ordinary activities
23,945
20,563
Staff costs
(28,061)
(17,364)
External expenses
(18,846)
(13,722)
Operating profit
(23,356)
(11,595)
Net financial income
3,664
(7,260)
Net profit
(20,213)
(19,292)
Net loss reached €20.2 million, representing a €0.9 million
increase over the year.
Operating loss reached €23.4 million, representing a €11.8
million increase, including €6.0 million for the IFRS accounting of
free shares allocated to Median's employees and top management in
October 2021 (with no impact on cash). External expenses increased
by €5.1 million. These included: purchases of clinical data,
services and studies linked to developing the iBiopsy® LCS
CADe/CADx SaMD as well as IT services and fees related to
technology infrastructure. Payroll costs were up €4.6 million.
The robust increase in revenue of €3.1 million and margin growth
generated by the iCRO business nevertheless helped reduce the
impact of development costs on the operating margin.
Financial income totaled €3.7 million and stemmed primarily from
an adjustment under IFRS accounting, with no impact on Median
Technologies’ cash, consisting of valuing the equity warrants
issued in favor of the EIB when the first €15 million tranche of
the loan was drawn in H1 2020. This valuation was impacted by
changes in Median’s share price since the issuance of the warrants.
It was accounted for in the statement of financial position under
financial instruments, and will not impact Median's cash
position.
Median Technologies informs its shareholders
and the financial community that its annual financial report on the
accounts for the year ending December 31, 2022 has been made
available and filed with the French financial markets 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' 2018
Reference Document. 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: Median Technologies provides
innovative imaging solutions and services to advance healthcare for
everyone. We harness the power of medical images by using the most
advanced Artificial Intelligence technologies, to increase the
accuracy of diagnosis and treatment of many cancers and other
metabolic diseases at their earliest stages and provide insights
into novel therapies for patients. Our iCRO solutions for medical
image analysis and management in oncology trials and iBiopsy®, our
AI-powered imaging platform for the development of Software as
Medical Devices (SaMD) help biopharmaceutical companies and
clinicians to bring new treatments and diagnose patients earlier
and more accurately. This is how we are helping to create a
healthier world.
Founded in 2002, based in Sophia-Antipolis, France, with
subsidiaries in the US and Shanghai, Median has received the label
“Innovative company” by BPI Financement and is listed on the
Euronext Growth market (Paris) ISIN code: FR0011049824 – Code
MNEMO: 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.
3 A radiological CADe device is “intended to identify, mark,
highlight or otherwise direct attention to portions of an image
that may reveal abnormalities during interpretation of images by
the clinician.” A CADx device is “intended to provide information
beyond identifying abnormalities, such as an assessment of
disease.” (FDA source).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230420005609/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
ggasparetto@actifin.fr
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