Trinity Delta Home use study supports WSD4000 development

Home use study supports WSD4000 development

Lighthouse | 15 January 2025

Share this note

Futura Medical has successfully completed the WSD4000 Home User Study, with results confirming the positive outcomes from the previous 16 subject single-blind randomised crossover study. The home study followed the same format but, as with the Eroxon mens’ study, allowed the women to evaluate WSD4000 in a more relaxed and less clinical environment. A majority of women reported increased vaginal lubrication, increased genital sensation, improved genital pleasure, and an improvement in their satisfaction with the sexual experience. Interestingly, 57% of women used the gel more frequently than required for the study over the four weeks.
Male sexual dysfunction is well characterised and studied, with premature ejaculation and erectile dysfunction being the most common. In contrast, sexual dysfunction in women is still poorly defined, as are the incidence and prevalence for various age groups. The main issues centre on desire and arousal dysfunctions, particularly in post-menopausal women. Echoing the situation with men, prevalence increases with age, from c 22% in ages <20 years to c 76% in women aged 40-50. Sexual dysfunction in women does adversely affect physical health and emotional well-being.
WSD4000 is a topical treatment, similar to Eroxon (MED3000), designed for sexual dysfunction in women. The regulatory pathway has been discussed with the FDA, with a similar clinical trial profile and “least burdensome” study principles advocated for MED3000. We expect the existing Eroxon partners to show a strong interest in broadening their sexual health positioning (eg Eroxon Intense), particularly given the commercial appeal of a clinically proven OTC product that addresses the needs of women. The consensus is that the needs of this sizeable population remain underserved, and, unlike male sexual dysfunction, there are few clinically proven treatment options.

Trinity Delta view: Futura Medical has successfully transitioned into a commercial healthcare company that is profitable and cash generative. Investor attention is focused on the market traction being gained by Haleon in the US, where even modest commercial success would be transformational. There is no market data for the rate of repeat purchases in Europe, which means, as discussed previously, revenues are impossible to forecast with any accuracy. Additional challenges include unpredictable launch dynamics and limited disclosure from partners. However, it is known that the market for ED treatments is sizeable. Now the female use data for WSD4000, whilst early, suggest it appears ideally placed to carve an attractive place for itself in a novel and significant female category. Our Futura Medical valuation of £392m, equivalent to 130p/share, currently includes no contribution for female use.

Lighthouse

15 January 2025


Price	30.00p
Market Cap	£91.1m
Primary exchange	AIM
Sector	Healthcare
Company Code	FUM

Corporate client	Yes

Company description

Futura Medical is the developer of innovative sexual health products; its core strength is in its research, development, and commercialisation of topically delivered gel formulations. Lead product Eroxon (MED3000) is approved as an OTC product for ED (erectile dysfunction) in Europe and the US.

Analysts

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Philippa Gardner
pgardner@trinitydelta.org
+44 (0) 20 3637 5042

Disclaimer

Trinity Delta Research Limited (“TDRL”; firm reference number: 725161), which trades as Trinity Delta, is an appointed representative of Equity Development Limited (“ED”). The contents of this report, which has been prepared by and is the sole responsibility of TDRL, have been reviewed, but not independently verified, by ED which is authorised and regulated by the FCA, and whose reference number is 185325.

ED is acting for TDRL and not for any other person and will not be responsible for providing the protections provided to clients of TDRL nor for advising any other person in connection with the contents of this report and, except to the extent required by applicable law, including the rules of the FCA, owes no duty of care to any other such person. No reliance may be placed on ED for advice or recommendations with respect to the contents of this report and, to the extent it may do so under applicable law, ED makes no representation or warranty to the persons reading this report with regards to the information contained in it.

In the preparation of this report TDRL has used publicly available sources and taken reasonable efforts to ensure that the facts stated herein are clear, fair and not misleading, but make no guarantee or warranty as to the accuracy or completeness of the information or opinions contained herein, nor to provide updates should fresh information become available or opinions change.

Any person who is not a relevant person under section of Section 21(2) of the Financial Services & Markets Act 2000 of the United Kingdom should not act or rely on this document or any of its contents. Research on its client companies produced by TDRL is normally commissioned and paid for by those companies themselves (‘issuer financed research’) and as such is not deemed to be independent, as defined by the FCA, but is ‘objective’ in that the authors are stating their own opinions. The report should be considered a marketing communication for purposes of the FCA rules. It has not been prepared in accordance with legal requirements designed to promote the independence of investment research and it is not subject to any prohibition on dealing ahead of the dissemination of investment research. TDRL does not hold any positions in any of the companies mentioned in the report, although directors, employees or consultants of TDRL may hold positions in the companies mentioned. TDRL does impose restrictions on personal dealings. TDRL might also provide services to companies mentioned or solicit business from them.

This report is being provided to relevant persons to provide background information about the subject matter of the note. This document does not constitute, nor form part of, and should not be construed as, any offer for sale or purchase of (or solicitation of, or invitation to make any offer to buy or sell) any Securities (which may rise and fall in value). Nor shall it, or any part of it, form the basis of, or be relied on in connection with, any contract or commitment whatsoever. The information that we provide is not intended to be, and should not in any manner whatsoever be, construed as personalised advice. Self-certification by investors can be completed free of charge at www.fisma.org. TDRL, its affiliates, officers, directors and employees, and ED will not be liable for any loss or damage arising from any use of this document, to the maximum extent that the law permits.