30 September 2025

Futura Medical plc

("Futura" or the "Group")

Results for the six months ended 30 June 2025

Futura Medical plc (AIM: FUM), the consumer healthcare Group behind Eroxon^®, that specialises in the development and global commercialisation of innovative and clinically proven sexual health products, announces its results for the six months ended 30 June 2025 ("HY25").

Operational overview:

Financial overview:

Post-period end and outlook:

Alex Duggan, CEO of Futura, commented:

"Since my appointment as interim CEO, I have been working closely with the Board and the wider team to carefully review the business, its priorities, and its strategic options. Our focus is on building a clear strategy that maximises value for shareholders, commercial partners, and employees.

Although the Company's performance during the period has not met expectations, with Eroxon early in-market results showing slower than hoped for consumer uptake and repeat sales, we believe it is still too early to draw firm long-term conclusions. Markets of this nature often take time to develop, and we remain confident there is meaningful global demand for a well-positioned topical product to support male sexual intimacy.

Additionally, we continue to believe that there is value in the Company's assets and therefore development plans for both Eroxon Intense and WSD4000 continue to progress. There is currently no known regulatory-approved OTC treatment available for impaired sexual response and function in women globally. We therefore see the opportunity for WSD4000 as an exciting market which we are well placed to serve, with our specialism in developing and bringing to market topically delivered gel formulations in sexual health products.

We are in the midst of a thorough strategic review to determine the best path forward. This process requires patience and care, and we appreciate the support of our investors as we take the necessary time to ensure the right long-term decisions are made. We will provide shareholders with a clear update once the review has reached its conclusion."

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.

WSD4000 is a topical treatment designed for the symptoms of impaired sexual response and function in women. There is currently no regulatory approved OTC treatment available for impaired sexual response and function in women. WSD4000 has the potential to be an effective, breakthrough treatment for the common symptoms associated with impaired sexual response and function, such as lack of desire, arousal and lubrication.

Chief Executive's Review

Since joining in August, I have undertaken a thorough review of the business's strategic and commercial plans. This review has been wide-ranging, covering the Company's sales and marketing strategies, the costs associated with running the business, and other potential strategic options available to the Company. The purpose of this work has been to gain a clear understanding of the current position, assess the challenges, and identify the most effective paths forward.

H1 Performance and Operational Review 

Financial performance

Revenue for the period was £1.0m, reflecting slower than anticipated in-market sales of Eroxon. As a result, initial 2024 inventory orders are still being utilised, which has in turn suppressed demand in 2025. Revenue in the period was split across geographies, with 50% generated from royalties in the US market, 48% from product sales in the EU and UK, and the balance from product sales in LATAM and the Middle East.

Underlying gross profit was £0.73m, which excludes a £0.49m provision for potential inventory obsolescence based on expected lower forecast demand. Despite this provision, the stock currently remains both usable and saleable.

The Group recorded a loss after tax of £6.59m. This figure includes £4.05m of exceptional items, primarily related to the impairment of plant and equipment due to reduced production demand and the final asset payment due in H2 2025 and the provision related to inventory write-down for risk of obsolescence. It also incorporates a £0.65 million non-cash charge for prior period share-based payments. Excluding these exceptional and non-cash items, the adjusted loss after tax was £2.0m.

As at 30 June 2025, the Group's cash position stood at £3.69m.

An RNS was released on 19 September regarding our expected FY 2025 performance. As outlined in that RNS, in-market sales of Eroxon have been slower than originally anticipated, a trend that has continued across all markets, most notably in the US where the market size and potential is considered to be the greatest. This has meant that royalties from the US market are now expected to be lower than previously anticipated and that initial inventory orders from our distributors continue to meet current year demand and so in turn this impacts the requirement for stock replenishment by those partners.

Alongside this sales trend, under the terms of the Company's agreement with Haleon, a payment of $2.5m is due upon the granting of a US Patent for Eroxon ("IP Milestone") that meets the contractual definition of a valid patent claim. All filings have been made and in previous forecasts it had been anticipated that this milestone would be achieved in FY 2025, with the payment forming a portion of overall revenue in FY 2025; however this is now expected to crystalise in H1 2026. The US Patent office is currently evaluating the potential grant and external legal advice indicates a high probability of patent grant and that the milestone payment will be triggered.

As previously announced, as a result of slower sales across all markets and with the US patent milestone payment now expected to fall in H1 2026, the Company expects revenues for FY 2025 to be materially below expectations. Therefore, revenue for FY 2025 is now expected to be between £1.3m and £1.4m.

Cash and cash equivalents stood at £2.71m at the end of August 2025, which, subject to a number of variables, is currently expected to provide working capital into January 2026. This takes into account the impact of the IP Milestone grant timing and assumes no growth in revenue or other sources of income. Please refer to Note 3 of the Interim Financial Statements regarding going concern and material uncertainty.

Further market launches but challenges around sustaining consumer uptake

At the close of the period, Eroxon^® has been launched and is now available in over 25 countries.

The following table shows a breakdown of where Eroxon has been launched at the end of this, through which partners, and on which operating model. As a reminder, to date, Eroxon has been launched using two different operating models:

Europe:

Overall partner sales in Europe declined versus the previous six months. This is largely a comparison effect against an exceptional H2 2024, when heavy investment in France, Spain and Portugal generated very high sell-in levels. It is too early to judge true like-for-like performance although the declining trend is steeper than expected but likely to be caused by a combination of consumer repurchase rates, media spend phasing and consumer targeting.

In H1 2025, our partner Cooper Consumer Health expanded into six additional countries across Northern and Eastern Europe: Denmark, Estonia, Latvia, Lithuania, Hungary and Romania. Hungary has seen the best market reception so far, obtaining a leading positioning in the OTC sexual health category in February due to the positioning of the product within the market and having a Healthcare Professional (HCP) as the main consumer engagement channel. 

Current stocks in all European markets remain high, reflecting both the scale of initial sell-in and lower consumer purchase rates than predicted by Cooper.

US:

Following launch in October 2024, as previously announced, progress in H1 2025 has been slower than anticipated. While distribution levels remain strong, market performance has not yet met initial Haleon or Company forecasts.

In addition, just under a third of US brick and mortar retail stockists have placed Eroxon^® in locked displays for local security reasons, and some consumers are therefore hesitant to ask for assistance; this effect had not been expected or planned for by Haleon. E-commerce, particularly Amazon, has attracted a broader range of users, some of whom may be less suited to the product, and this has likely meant lower than expected consumer ratings on the Amazon platform.

Middle East:

Sell-in across the region has declined compared with the previous six months, where high sell-in activity from the local sales force in KSA drove strong volumes.

Labatec has further expanded into Kuwait in May, adding to the five Middle Eastern countries where Eroxon^® is now represented.

Strict sexual health advertising restrictions and sensitivities mean direct-to-consumer activity is severely limited, leaving HCPs, urologists, and pharmacists as the main consumer engagement channel, while PDE5 inhibitors remain widely prevalent.

Latam - Mexico:

Following the mid-August 2024 launch in Mexico, H1 2025 saw continued growth in retail distribution and a significant expansion of M8's digital campaign, albeit below the partner's forecast.

The digital campaign included the launch of new social media channels, podcast features, physician-led workshops, and the onboarding of a fresh pool of healthcare professionals and lifestyle influencers. These efforts have delivered impressive reach, successfully driving consumer interest and engagement across both online and offline channels. As well as continuing to expand distribution, M8 are actively reviewing their target audience and refining engagement strategies to improve alignment with consumer expectations and encourage repeat purchases.

Leveraging our innovative and experienced R&D capability

Eroxon Intense

Eroxon Intense, our in-development product designed to help those men who would prefer a stronger sensation, remains on track to achieve regulatory approvals in EU and USA by the end of 2025. Due to more stringent data requirements in the US, product with a 24-month shelf life (judged to be the minimum for launch) will not potentially be available until Q3 2026. The EU will have product with a 48-month shelf life potentially available from Q1 2026.

Following successful proof of concept work which demonstrated a strong preference for the enhanced sensorial effects of Intense, a more extensive Home User Study in up to 200 UK ED subjects has been commissioned and will be funded from existing cash reserves. The study compares the new Intense formula with the existing marketed Eroxon formula, with each product being used over a four-week period. The primary goal is to demonstrate improved product performance through the enhanced sensorial effect on the glans penis.

We are expecting the results of the Eroxon Intense Home User Study by the end of October 2025. Depending on the outcome of the Home User Study, a strategic decision will be made with regards to updating the existing Eroxon product, adding a second strength variation or if preferred in some markets creating a new brand.

WSD4000

WSD4000 is our in-development topical treatment designed for the symptoms of impaired sexual response and function in women. There is currently no known regulatory-approved OTC treatment available for impaired sexual response and function in women globally. We therefore see this as an exciting market opportunity which we are well placed to serve, with our specialism in developing and bringing to market topically delivered gel formulations in sexual health products. WSD4000 has the potential to be an effective, breakthrough treatment for the common symptoms associated with impaired sexual response and function, such as lack of desire, arousal and lubrication.

What is the market opportunity?

We have conducted an initial Home User Study which found that:

We continue to have productive meetings with the FDA to design the program needed to achieve marketing authorisation as a first in class (De Novo) medical device. Meanwhile, an Early Feasibility Study (EFS) previously requested by the FDA has commenced, with results expected to be available Q1 2026. Once the results of this EFS are understood, a decision will be made around the progression to and timing of a Phase 3 trial in the US which will be needed to support medical device status.

Post-period strategic findings

The Board is continuing its strategic review of the business as a whole and will update the market as appropriate.

Regarding Eroxon, from a product perspective, whilst it is evident there remains a global demand for a well-positioned topical product to support male sexual intimacy and the Eroxon product is shown to be clinically effective in addressing this issue, initial in-market results show that our partners are not seeing their expected level of consumer uptake or repeat sales.

It is my expectation that this mismatch between clinical efficacy and market performance is due to both the positioning of the product (an over-expectation of what the Eroxon product will deliver and to which consumer group of ED sufferers) and the efficacy of the product which needs to be binary in effect (potentially the existing formulation and the instructions for usage).

As previously announced, clinical trials demonstrated efficacy of the first Eroxon formulation in 63% of men, underscoring that while Eroxon^® is effective for a significant proportion of users, it may not work for all ED sufferers due to the wide range of underlying causes of ED. 'Efficacy' in this category is often binary in men i.e. an erection is achieved or not, therefore it is unlike many other Consumer Healthcare categories where a degree of efficacy can still be seen by consumers as positive.

One of the product's key strengths is that it doesn't require a prescription or any HCP involvement, making it highly accessible. However, this also means that once broad distribution is achieved, online and in-store, anyone can purchase it, regardless of suitability or understanding of how it works.

Given these conditions, the way Eroxon is marketed and sold is critical. Any shortcomings in execution can lead to a perception that the product is ineffective, which in turn drives negative reviews - even if the product itself is sound. Issues therefore lie in:

Close attention is now being made on these failing parameters through:

Next steps and outlook

Cost cutting and funding

As announced on 19 September, in light of the reduced operating cashflow and the delay of the IP Milestone payment, and in order to extend the Company's cash runway, a thorough review of the costs associated with the Company as a whole has been undertaken and a cost cutting programme has now been initiated.

Alongside this, as announced, the Company is exploring a number of different avenues to extend its cash runway, including considering commercial options and opportunities for financing.

While these cuts are painful and not what any incoming CEO would wish to do at such an early stage, it is essential for the future of the business. We are mindful that we need to maintain the ability to continue to support existing business and most importantly to ensure we can continue to do what the company does best - to develop innovative sexual health products and range extensions, using our regulatory expertise to prepare for market launches through our global network of commercial partners.

As previously announced, as part of the ongoing review of the business, the Board is considering a range of potential options to create shareholder value including but not limited to additional or alternative partnering/licensing and distribution arrangements for Eroxon alongside Eroxon Intense and WSD4000. This may include the sale of one or more assets of the business. The Board continue to believe that there is value in the Group's assets and therefore development plans for both Eroxon Intense and WSD4000 continue to progress. We will update the market on any developments in due course.

Leadership changes

In July, Jeff Needham and James Barder agreed to step down from the Board as Non-Executive Chair and Chief Executive Officer. Additionally, in August Angela Hildreth notified the Board of her intention to step down as Finance Director and Chief Operating Officer. Angela will remain in her role and as a Director of the Company during her six-month notice period to early February 2026, continuing to support the Group and overseeing an orderly handover of responsibilities once a successor has been appointed.

At the beginning of August, I stepped into the role as Interim CEO at a pivotal juncture for the Company and since then I have been working closely with the Board and the wider team in my review of the business, its priorities, and its strategic options. Following this review, and as part of the cost-cut and organisation re-structure, the Board will initiate a search for a permanent CEO to lead the business forward in its next period of development. The Board expects to complete this leadership search for a CEO and FD/COO in early 2026, and an announcement will be made when appropriate.

Summary

Whilst I am aware that the Company performance over the past 12 months following the launch of Eroxon hasn't been as anticipated, the Board and I are now clear about the key issues facing the Company, its products and our commercial partners.

While the outcome of any R&D work can never be guaranteed, the Board believes that there is significant value in the Group's assets and therefore development plans for both Eroxon Intense and WSD4000 continue to progress.

We are continuing to undertake a thorough review of the business and its operations to deliver a clear view on how best to take the business forward and expect to update the market on the conclusion of the review by Q1 2026. We wish to once again thank our supportive and long-standing shareholders for their ongoing patience during this necessary and urgent period of change.

Consolidated Statement of Comprehensive Income

For the six months ended 30 June 2025

Consolidated Statement of Financial Position

As at 30 June 2025

Consolidated Statement of Changes in Equity

For the six months ended 30 June 2025