- Launch of pivotal clinical studies for iBiopsy® LCS CADe/CADx
SaMD.
- Successful refinancing of €21.6 million, providing financial
visibility until 2025.
- Total year-to-date revenue of €17 million as of September 30,
2023, down versus 2022 revenue over the same period (€18.7
million).
- Order backlog at €62.7 million as of September 30, 2023,
impacted by cancelation of a biopharma study worth €2.9
million.
Regulatory News:
Median Technologies (Euronext Growth – ALMDT:PA) (Paris:ALMDT),
whose board of Directors approved the consolidated IFRS financial
statements for the first half of 2023 on October 18, 2023, today
announces its half-year results as well as business indicators for
Q3 2023 (unaudited).
Commenting on the results, Fredrik Brag, CEO, and co-founder of
Median Technologies, said:
“During the first three quarters of 2023, we made significant
strides regarding iBiopsy®. July saw us launch our AI-based
iBiopsy® Lung Cancer Study CADe/CADx Software as Medical Device
pivotal studies. These are key milestones in our roadmap to obtain
marketing authorizations for our Software as Medical Device for the
US and European markets. AI-based medical imaging software
solutions are revolutionizing cancer drug development, cancer
patient diagnosis, treatment, and survival. Regarding lung cancer,
which is the number one cancer killer globally, patients diagnosed
in stage 1 have a 92% survival rate while patients diagnosed at an
advanced stage have a mortality rate of 94%1. In the US
alone 14.5m people are eligible for a reimbursed imaging LCS test,
and AI-based imaging tissue characterization is now also reimbursed
at a rate of $650 creating a vast target market. Median is poised
to play a pivotal role to help significantly reduce the lung cancer
mortality rate through more effective diagnosis of early-stage
patients.
In July 2023, we raised €21.6 million, guaranteeing financial
visibility until 2025. We intend to draw the second tranche of the
EIB loan for approximately €10 million before year-end.
As regards the iCRO business, we were successfully inspected by
the US FDA and the Chinese NMPA in July and August on a phase I/II
oncology study. These were our 4th and 13th successful inspections
with the FDA and NMPA respectively. Year-to-date, iCRO revenue was
negatively impacted by soft bookings due to China’s Covid lockdown
in 2022. Business has picked up for iCRO in China, with a robust
ramp up in new requests for proposals and contracts. What’s more,
we are experiencing strong interest from major US pharma
companies.”
Significant events for Q3 2023
iBiopsy® LCS
CADe/CADx clinical development plan
In July, the Company announced significant and strategic
progress for its iBiopsy® Lung Cancer Screening (LCS) CADe/CADx2
SaMD with the onboarding of all clinical sites involved in the two
LCS pivotal studies and the launch of the pivotal validation plan.
Results from these two studies will be used to file for FDA 510(k)
clearance for marketing authorization in the US as well as to
obtain CE mark – a prerequisite to securing marketing
authorizations in European countries.
Company refinancing and cash
position
In July, Median announced a successful €11.6 million capital
increase through a private placement and public offering at a
subscription price of €4.70 per share, together with the finalized
issuance of €10 million convertible bonds at a conversion price per
share of €6.458, subscribed by Celestial Successor Fund, LP, one of
Median’s long-standing, reference shareholders. As of September 30,
2023, cash and cash equivalents were substantially bolstered,
ending at €26.5 million. Cash position included receipt of France’s
2022 research and innovation tax credit for €1.6 million.
iCRO Business Performance
During Q3, Median’s iCRO3 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 highest quality track
record.
Q3 2023 revenue for the Group came to €5.6 million, versus €6
million in Q3 2022. Combined total revenue for Q1, Q2 and Q3
amounted to €17 million. All revenue was generated by the iCRO
business line. The latter provides imaging services to the
biopharmaceutical industry for oncology clinical trials the world
over.
In Q3 2023, iCRO order backlog4 was adversely affected by a €2.9
million study cancelation. As of September 30, 2023, backlog
amounted to €62.7 million.
Financial information as of June 30,
2023 (IFRS consolidated financial statements)
Cash-Flow Statement
Cash flow (€ thousands)
06/30/2023
(6 months)
06/30/2022
(6 months)
Operating cash flow
(9,045)
(5,682)
Change in operating working capital
requirement
(2,668)
(4,390)
Net cash flow from operating
activities
(12,083)
(10,072)
Net cash flow from investing
activities
(514)
(662)
Net cash flow from financing
activities
(324)
(155)
Impact of changes in exchange rates
(207)
120
Net change in cash and cash
equivalents
(13,128)
(10,769)
Cash at beginning of period
21,467
39,006
Cash at end of period
8,338
28,236
Over the first half of 2023, the Company stepped up the
development of iBiopsy®, with a focus on iBiopsy® Lung Cancer
Screening (LCS) CADe/CADx SaMD. This resulted in an increased cash
flow deficit, offset in part by the margins generated from the iCRO
business.
Consolidated income statement under
IFRS
€ thousands
H1 2023
H1 2022
Revenue from ordinary
activities
11,394
12,839
Personnel costs
(13,360)
(13,707)
External costs
(8,910)
(9,362)
Operating profit (loss)
(11,189)
(11,010)
Net financial income
1,221
2,441
Net profit (loss)
(10,088)
(8,881)
Net loss was €(10.1) million, up €1.2 million versus the same
period in 2022.
Operating loss remained relatively stable at €(11.2) million,
versus €(11.0) million in 2022. Revenues at €11.4 million were down
€1.4 million year-on-year, due to soft bookings in China during
last year’s lockdown period. Parallel to this, payroll expenses
were up €2.1 million, with the Company continuing to attract new
talents to enhance its organization. The above expenses were offset
by the more minimal impact of share-based payments at €2.5 million,
and external expenses, which decreased by €0.5 million.
Mainly driven by the valuation of EIB warrants, net financial
income stood at €1.2 million, representing a year-on-year decrease
of €1.2 million.
Median Technologies informs its shareholders
and the financial community that its half year financial report on
the accounts for the half year ending June 30, 2023, has been made
available and filed with the French financial market authority
(Autorité des Marchés Financiers).
The half year 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,
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: 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/ML tech-based suite 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 a
subsidiary in the US and another one in Shanghai, Median has
received the label “Innovative company” by the BPI and is listed on
Euronext Growth market (Paris). FR0011049824– ticker: ALMDT. Median
is eligible for the French SME equity savings plan scheme
(PEA-PME). For more information: www.mediantechnologies.com
------------------
1
https://www.redjournal.org/article/S0360-3016(19)30110-5/fulltext 2
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.” Source: FDA 3 Imaging Contract Research Organization 4
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/20231019355934/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
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