REG - Futura Medical PLC - Futura Medical AGM Statement

Futura MedicalAnnouncement

22/06/2023 07:00

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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® 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®
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 £1.5 million.

In addition to the benefit of these first revenues from Eroxon®, 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 £4.37 million cash and by further milestone payments of
approximately £250,000.

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® 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® 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® and Viagra®, 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 (http://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® technology. Each DermaSys® 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® 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® with a key claim of "Helps you
get an erection within 10 minutes". Eroxon® 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 (http://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
(http://www.futuramedical.com/) .

 

 

 

 

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