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RNS Number : 5032D
Futura Medical PLC
22 June 2023
22 June 2023
Futura Medical plc
("Futura" or the "Company")
AGM Statement
Futura Medical plc (AIM: FUM), a pharmaceutical company
developing a portfolio of innovative products based on its
proprietary, transdermal DermaSys(R) drug delivery technology and
currently focused on sexual health and pain, is pleased to announce
that the following update will be provided at the Company's Annual
General Meeting ("AGM") which is being held at 10:00 am BST later
today.
Financial Update
We have been highly encouraged by the early growth trajectory of
Eroxon(R) following launch. Both initial orders of Eroxon by our
partners and in-market demand have been in line with our
expectations and should continue to build as partners expand sales
channels, numbers of outlets and new geographies. Whilst it is too
early in the launch to give formal guidance for the full year, we
are pleased to report that net reported revenues(1) for the six
months ending 30 June 2023 will be not less than GBP1.5
million.
In addition to the benefit of these first revenues from
Eroxon(R), our balance sheet has also been further strengthened
during the first six months of 2023 following the exercise by one
of our long-standing and supportive institutional investors of
warrants originally issued in 2019 resulting in the receipt of
GBP4.37 million cash and by further milestone payments of
approximately GBP250,000.
MED3000 - A year of regulatory progress with initial
commercialisation achieved
2022 was another strong year, with the Company continuing its
transformation, building on the momentum achieved in the prior
year, as it entered the commercialisation phase and positioned
itself to receive its first significant revenues in 2023. Two major
highlights were the Company's partnering deal for the
commercialisation of Eroxon(R) in the EEA, UK and Switzerland with
Cooper Consumer Health ("Cooper"), a leading European independent
self-care organisation, and delivering highly positive data from
the confirmatory "FM71" Phase 3 study of MED3000 in erectile
dysfunction ("ED").
Momentum at Futura continues to build. Following the
announcement of the exclusive licensing agreement with Cooper in
2022 and as part of this close strategic partnership, in April 2023
we announced that Eroxon(R) was available in retail pharmacies and
online in the UK and in Belgium having launched in March 2023.
The US remains the largest market opportunity globally for ED
treatments and we were delighted to be granted marketing
authorisation early in June 2023 by the US FDA which now enables
MED3000 to be legally marketed in the USA as the first topical
treatment for ED available over the counter without the need for a
prescription and with a highly differentiated 10-minute onset of
action label claim. Oral PDE5i medications, such as Cialis(R) and
Viagra(R), require a doctor's prescription in the USA and typically
are required to be taken at least 30 minutes in advance of use.
The granting of marketing authorisation is a huge milestone for
the Company as the FDA sets a very high standard in evaluating the
effectiveness and safety of De Novo Medical Devices and this
approval is a major de-risking event for the Company. This will
support our strategic priority of unlocking the value of the US
market and we look forward to further updating shareholders on our
US commercialisation plans in due course.
Futura made significant progress in 2022 and has continued to do
so in 2023 and we would like to thank our shareholders for their
continued support and our employees for their significant
contributions in driving Futura towards becoming a profitable
company.
1. Net revenue represents product sales to commercial partners at agreed transfer prices
-ENDS-
For further information, please contact:
Futura Medical plc
James Barder, Chief Executive Officer
Angela Hildreth, Finance Director and COO
Email: investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
www.futuramedical.com
Nominated Adviser and Sole Broker:
Liberum
Phil Walker/ Richard Lindley/ Ben Cryer
Tel: +44 (0) 20 3100 2000
For media enquiries please contact:
Optimum Strategic Communications
Hollie Vile/ Jonathan Edwards/ Zoe Bolt
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 882 9621
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company
developing a portfolio of innovative products based on its
proprietary, transdermal DermaSys(R) technology. Each DermaSys(R)
formulation is separately patented and specifically tailored for
the selected indication and application, as well as being optimised
for clinical efficacy, safety, administration and patient
convenience. The products are developed for the prescription and
consumer healthcare markets as appropriate. Development and
commercialisation strategies are designed to maximise product
differentiation and value creation whilst minimising risk.
MED3000 is Futura's topical gel formulation that is a novel
treatment for erectile dysfunction (ED) through a unique
evaporative mode of action. Futura has conducted two Phase 3
studies using MED3000 in ED; FM57 study which enabled Futura to be
granted a CE Mark in 2021 and FM71 which enabled Futura to be
granted US marketing authorisation. Both studies demonstrated that
MED3000 presents an effective clinically proven treatment for ED
with a rapid speed of onset and a favourable benefit versus risk
profile ideally suited for an 'Over the Counter'
classification.
Eroxon(R) is FDA approved in the US, CE marked in Europe and
UKCA marked in the UK as a clinically proven topical treatment for
adult men with erectile dysfunction under the brand Eroxon(R) with
a key claim of "Helps you get an erection within 10 minutes".
Eroxon(R) is the agreed brand name in certain regions such as the
EU whereas MED3000 continues to be the internal code name used by
the Company and also in reference to countries where regulatory
approval or commercial distribution agreements have not yet been
achieved. www.eroxon.com
Futura is based in Guildford, Surrey, and its shares trade on
the AIM market of the London Stock Exchange. www.futuramedical.com
.
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END
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