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 revenues¹ 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: [email protected]

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: [email protected]

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

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com.