Futura Medical Regulatory News (FUM)

6 February 2024

Futura Medical plc

("Futura" or the "Company")

Trading Update

Transformational year, generating first meaningful revenues and laying the foundations for significant growth acceleration through world leading partners

Futura Medical plc (AIM: FUM), the consumer healthcare company behind Eroxon, that specialises in the development and global commercialisation of innovative and clinically proven sexual health products, today provides a trading update for the year ended 31 December 2023 ("FY23").

FY23 was a transformational year, with the Company successfully executing its initial market launches of Eroxon, the first clinically proven topical treatment for erectile dysfunction ("ED") to be available without a doctor's prescription ("over the counter"), through its distribution partners.

The first meaningful revenues generated from product sales and the broader success of the UK launch have been a catalyst for significant strategic progress across multiple markets. The launch, success of the partnerships and consumer take up of the product, clearly illustrates that Eroxon is helping to satisfy an unmet need in the market and highlights the scale of the opportunity across the globe.

Highlights

During FY23, Eroxon received regulatory approval in our key target markets, including FDA approval in the US, the largest market for ED in the world. Following this, the Company was delighted to announce that it had entered into an agreement with Haleon plc, the world leading consumer healthcare company, for exclusive marketing & distribution rights in the US. Futura continues to work with Haleon on preparation for the US launch and looks forward to updating shareholders in due course.

Futura's European distribution partner, Cooper, launched in the UK and Belgium in March, followed by soft-launches in France, Italy and Spain. The Company has been encouraged by the performance to date in these initial markets, with Eroxon taking >20% market share of approved ED treatments in the UK and Belgium within 12 months of launch. The success of the partnership to date was demonstrated through the recent extension of the licencing agreement with Cooper post the year end until January 2029, with full launches in at least ten countries including key European markets such as France, Italy and Spain remaining on track to take place before April 2024. The allowance of Futura's EU patent for Eroxon until 2040 in all European markets further cements the intellectual property of the product as Cooper continues the roll out.

During the year, the Company also received a number of approvals including Saudi Arabia, Mexico and Australia and also launched in the UAE.

The Board expects to report its first meaningful revenues generated from product sales for the year to 31 December of circa £3.1m followed by a strong January, post period, as additional orders in excess of £0.5m were delivered in early January rather than December as originally planned. The Company delivered a gross margin of approximately 58% and has ended the period with a cash position of £7.7m, providing a solid foundation for Futura as it enters 2024.

The Company expects to announce its full year results ended 31 December 2023 in April 2024 and will confirm the date in due course.

James Barder, CEO of Futura, commented:

"I am incredibly proud to report that we have delivered on the three key objectives that we set out in 2023: achieving regulatory approval in the US; progressing commercial discussions by securing a standout distribution partner in Haleon for the largest consumer healthcare market in the world and reporting our first meaningful revenues. The delivery of this progress, alongside the fact that we have an award-winning product, has given us a robust and broad platform to build upon in the year ahead.

"We are helping to address an issue that impacts 1 in 5 men globally across all adult age brackets, with approximately half of all men over 40 experiencing ED and 25% of all new diagnoses being in men under 40. The availability of Eroxon as the first over the counter ED product without the need for a prescription or pharmacist intervention, as opposed to by prescription, significantly improves access for men or their partners without the normal cost or embarrassment issues often associated with consultation of a healthcare practitioner.

"With the size of the target market and the progress we are making to reach it, we look forward to the year ahead and confident of considerable growth acceleration over the medium term - delivering progress in sales across multiple countries and broadening distribution by launching in new markets."

Contacts:

Notes to Editors:

Futura Medical plc (AIM: FUM) is the developer of innovative sexual health products, including lead product Eroxon. Our core strength lies in our research, development and commercialisation of topically delivered gel formulations in sexual health products.

Eroxon, Futura's clinically proven lead product, has been developed for the treatment of Erectile Dysfunction ("ED"). The highly differentiated product, which is the only topical gel treatment for ED available over the counter and helps men get an erection in ten minutes, addresses significant unmet needs in the ED market.

ED impacts 1 in 5 men globally across all adult age brackets, with approximately half of all men over 40 experiencing ED and 25% of all new diagnoses being in men under 40.

Futura has distribution partners in place in a number of major consumer markets including Haleon in the US, the largest market for ED in the world, and Cooper Consumer Health in Europe. Eroxon has been nominated for a number of healthcare industry awards and has won two to-date.