30 January 2025

Futura Medical plc

("Futura" or the "Company")

FY24 Trading Update and FY25 Outlook

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 an unaudited trading update for the year ended 31 December 2024 ("FY24") and an update on the outlook for the year ending 31 December 2025 ("FY25").

Key points

FY24 Trading Update

The Board expects to deliver FY24 Revenue and Profit after Tax ahead of market expectations. Following the launch of Eroxon across a number of key markets, including the US, Europe and Latin America, revenues grew significantly in the year to at least £13.7 million (2023: £3.1 million). The Company delivered a blended gross margin² of approximately 73% and net cash at year end was £6.6 million (2023: £7.7 million).

Eroxon

Since the half year, Eroxon has continued to be launched in new markets alongside Cooper Consumer Health, helping to further address the growing needs within the OTC sexual health market.

October's launch in the US, one of the largest ED markets in the world, was a landmark for the Company.  Following the October 2024 US launch, early signs are promising with positive retailer uptake and strong retail launch execution performance feedback and all parties remain confident that there is a significant market opportunity to address. Consumer data from the first quarter post launch has provided insights and learnings and Haleon is committed to implementing those learnings to optimise their next phase of the launch, including removing barriers to purchase, such as lockboxes that prevent theft but require the intervention of a shop assistant when purchasing and therefore impact sales. Haleon continues to deploy significant investment with marketing campaigns continuing, including TV advertising that refines consumer messaging and targets those men where research suggests Eroxon is most effective.

Whilst Eroxon is now available in many major markets across Europe and the UK, the timing of further launches within the EU have been slower than originally anticipated and we are working closely with our commercial partner Cooper Consumer Healthcare in accordance with our commercial agreement to address these issues and gain greater visibility around the challenges Cooper faces in generating greater consumer awareness in the potential target market for Eroxon. 

New Product Development Pipeline

Broadening the Company's clinically proven product range, whilst being mindful of costs and focusing on return on investment for shareholders remains a strategic objective for the Board. FY24 saw the business make good progress, with the expansion of its new product development pipeline. Eroxon Intense, which is on track for marketing authorisation by the end of 2025, will broaden the existing Eroxon range and benefit those men who would prefer a stronger sensation while using the product. WSD4000, a topical gel for the treatment of symptoms of sexual dysfunction in women, represents an opportunity to address a large and underserved market and has delivered positive results from its Home User study, details of which can be found in the Company's announcement of 15 January 2025.  

FY2025 Outlook

Futura and its partners remain confident in the opportunity to address the unmet need of accessible erectile dysfunction treatment in our target markets. Whilst sales levels are satisfactory for such an early stage in the product journey, the rate of consumer sales expansion is falling short of early estimates.  As previously noted, Eroxon is an entirely new product in an entirely new category and therefore predicting the sales, royalties and milestones is particularly challenging, with milestone payments very significant and unpredictable in their timing.  Whilst launches have been well executed and met with strong retailer commitment, there have been learnings which require marketing strategies to be optimised in the period ahead. This, along with some launch delays in markets outside of the US has resulted in a slower ramp-up and expansion of retail sales.  While early in the new fiscal year and early in the launch phase, the Board believes the prudent approach to FY25 is to revise its forecasts accordingly.

Noting the above, the Company currently anticipates product sales and royalties in FY25 will be approximately 50% lower than previously expected and that the Company is unlikely to meet the requirements for the sales-based milestone payments expected during FY25. As a result, the Company now expects FY25 revenue will be materially below expectations and as a result will make a loss after tax in FY25 against previous expectations of profitability³

The Group's balance sheet remains robust with cash of £6.6 million at 31 December 2024 which provides working capital through to H2 2026.

James Barder, CEO of Futura, commented:

"2024 saw us bear the early fruit of the hard work and disciplined investments we made to successfully bring a new, unique product to market. The results we achieved last year, with maiden profit delivered, are thanks to the hard work and expertise of our teams and partners. The launches of Eroxon around the world, including the US, for a large and underserved market, were significant milestones for Futura and provide the springboard for further growth.

Whilst it has been slower than anticipated to generate consumer awareness, and resulting sales, in a completely new product in a new consumer market that naturally has some stigma attached to it, we, and our partners, remain confident in the future prospects for Eroxon. Our commercial partners are committed to building the Eroxon brand based upon the learnings gleaned post-launch, especially within the key US market, as we look to meet the unmet demand for a product of this nature and take advantage of the opportunities available to us."

The Company expects to report its full year results in April 2025.

¹ The Company believes that, prior to this announcement, market expectations for 2024 performance in terms of revenue and   profit after tax were £13.4 million and £0.5 million respectively

² Blended gross margin across product sales, royalties and milestones

³ The Company believes that, prior to this announcement, market expectations for 2025 performance in terms of revenue and   profit after tax were £18.5 million and £6.3 million respectively

The information communicated in this announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014 as amended by the Market Abuse (Amendment) (EU Exit) Regulations 2019.

Contacts:

Notes to Editors:

Futura Medical plc (AIM: FUM) is the developer of innovative sexual health products, including lead product Eroxon^® and products WSD4000 and Eroxon^® Intense. Our core strength lies in our research, development and commercialisation of topically delivered gel formulations in sexual health products.

Sexual health issues are prevalent in both men and women. 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. Around 60% of women experience at least one symptom of sexual dysfunction, and only one in four women seek professional help, and remain chronically underserved.

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. Eroxon^® has been nominated for a number of healthcare industry awards and has won two to-date.

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.