- Record high revenue of €5.7 million in Q1 2022, up 9.2%
compared with Q1 2021
- Further growth in the order backlog to €62.3 million as of
March 31, 2022, up 18.4% compared with March 31, 2021
- First quarter press release on the outstanding
detection/characterization performances for the iBiopsy® Lung
Cancer Screening CADe/CADx software as medical device (SaMD) and
start of discussions with the FDA
- Revenue of €20.5 million as of December 31, 2021, up 52.4%
compared to December 31, 2020
- Cash and cash equivalents of €33.1 million as of March 31,
2022
Regulatory News:
Median Technologies (Euronext Growth - ALMDT) (Paris:ALMDT)
whose Board of Directors met on April 20, 2022 to close the
consolidated financial statements for the year ending December 31,
2021, announces its full-year results for 2021 and business
indicators for the first quarter of 2022.
First quarter 2022: initiation of regulatory interactions
with the FDA for the iBiopsy® LCS CADe/CADx1 software as medical
device (SaMD) and growth in the iCRO order backlog2
During the first quarter of 2022, Median Technologies announced
it had completed the CADe/CADx integration for its iBiopsy® Lung
Cancer Screening (LCS) software as medical device (SaMD), which has
delivered outstanding sensitivity and specificity performances (see
press release of March 22). On March 3, Median also announced it
had submitted a 513(g) filing to the FDA. This structuring stage is
the first step in Median’s interactions with the FDA, which are set
to run until the iBiopsy® LCS CADe/CADx SaMD obtains marketing
approval.
As of March 31, 2022, Median’s first quarter revenue stood at
€5.7 million, up 9.2% relative to revenue in the year-earlier
period. Revenue was generated by the iCRO3 business, which provides
services to the global biopharmaceutical industry for image
management in oncology trials.
The order backlog stood at €62.3 million on March 31, 2022, up
18.4% relative to March 31, 2021 (€52.6 million).
On March 31, 2022, cash and cash equivalents totaled €33.1
million.
“2021 was a record year for Median with revenue of €20.5
million. Order intake was excellent during the fourth quarter after
a fairly stable level for the backlog over the first three
quarters. The first quarter of 2022 confirmed this momentum with
the order backlog rising 18.4% relative to March 31, 2021. At the
same time, revenue on March 31, 2022 was up 9.2% compared to the
year-earlier period, and was the best quarterly level ever recorded
by the Group,” stated Fredrik Brag, CEO and founder of Median
Technologies. “During the first quarter of 2022, we communicated
the outstanding detection/characterization performances of our
iBiopsy® LCS CADe/CADx software as medical device, which could help
save many lives through the early detection of lung cancer in
clinical care. iBiopsy® is also generating major interest from our
pharma partners. The first regulatory exchanges with the FDA have
now been initiated and we plan to start our pivotal trials late
2022”.
2021 results: continued growth for Median and investments in
the iBiopsy® software as medical device (SaMD)
On January 17, 2022, Median reported business indicators for
2021 and now confirms:
- Revenue as of December 31, 2021 of €20.5 million, up 52.4%
relative to December 31, 2020,
- An order backlog as of December 31, 2021 of €58 million,
- Cash and cash equivalents of €39 million as of December 31,
2021.
As regards iBiopsy®, 2021 was highlighted by progress in the
development of iBiopsy® LCS CADe/CADx SaMD. CADx results were
presented at the Annual Meeting of the RSNA (Radiological Society
of North America) at the end of November 2021 in Chicago.
Financial information as of December 31, 2021 (consolidated
financial statements under IFRS accounting rules)
Consolidated statement of cash
flows
Cash flow (€K)
12/31/2021
12/31/2020
(12 months)
(12 months)
Operating cash flow
(8,340)
(8,008)
Change in operating working capital
requirement
(1,785)
2,549
Net cash flow from operating
activities
(10,125)
(5,459)
Net cash flow from investing
activities
(672)
(327)
Net cash flow from financing
activities
33,203
14,561
Impact of change in exchange rates
289
(75)
Net change in cash and cash
equivalents
16,315
7,615
Cash and cash equivalents
at the end of the period
39,010
16,315
In 2021, Median’s cash was strengthened following the capital
increase undertaken on March 25, 2021 for an amount of €26.6
million net of fees and expenses, and additional financing of over
€6 million related to the exercise of equity warrants maturing on
September 29, 2021.
Net cash flows from operating activities went from (€5.5)
million in 2020 to (€10.1) million in 2021, primarily due to the
sharp increase in working capital requirements related to growth in
the business and the acceleration in investments for the
development of the iBiopsy® software as medical devices. Operating
cash flow remained stable in 2021 relative to 2020.
Net income statement under IFRS accounting
rules
Net profit (loss ) (€K)
12/31/2021
12/31/2020
Revenue
20,547
13,478
Income from ordinary activities
20,747
13,591
Staff costs
(17,399)
(11,718)
External expenses
(13,845)
(9,468)
Operating results
(11,569)
(8,819)
Net financial results
(7,286)
(3,991)
Net results
(19,292)
(12,802)
The operating loss stood at €11.6 million, representing a €2.8
million increase over the year, of which €1.6 million for the IFRS
accounting of free shares for Median’s employees and top management
in October 2021 (with no impact on cash), and also in view of the
investments made in R&D works for the iBiopsy® platform.
Robust revenue and margin growth generated by the iCRO business
nevertheless helped reduce the impact of investments related to
iBiopsy® at the operating level.
The financial loss totaled €7.3 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 the
increase in the Median’s share price since the equity warrant
issue. It was accounted for in the balance sheet 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, 2021 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:
http://www.mediantechnologies.com/investors/
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 software as medical device 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), is listed on the Enternext® PEA-PME 150
index and has been awarded the Euronext European Rising Tech label.
For more information: www.mediantechnologies.com
1 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.” 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 Imaging Contract Research Organization
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version on businesswire.com: https://www.businesswire.com/news/home/20220421005711/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
Median Technologies (EU:ALMDT)
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