Futura Medical

Gearing up for further launches in 2023

Lighthouse | 5 April 2023

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  • Futura Medical’s preliminary FY22 financial results confirm that key events regarding the commercialisation of erectile dysfunction (ED) treatment MED3000 are progressing on track and as planned. These include the initial launches in Europe with partner Cooper Consumer Health, and in the US, where FDA regulatory clearance continues to be expected in Q223 and commercial partnering discussions are ongoing.
  • Cash at end-December 2022 was £4.0m (FY21: £10.4m), which with continued tight cost control should be sufficient well beyond key upcoming catalysts, ie the US regulatory decision and securing a US commercial deal. Initial MED3000 sales should also extend the runway and importantly, management expects to report first European revenues with interim results in September. Although visibility is currently limited on the magnitude of potential revenues, we note that “conservative” estimates have been used in the preparation of the financial statements on a going concern basis.
  • In the US, a full response to questions from the FDA and the requested non-clinical confirmatory data were submitted at end March, with MED3000 regulatory clearance expected during Q223 and discussions with several potential US partners underway. In Europe, MED3000, branded as Eroxon and sold by partner Cooper Consumer Health, became available in stores and retail pharmacies in Belgium on 1 April 2023 with other market launches expected shortly. Eroxon is already available through online channels in Europe. Launches are also planned with partners in the Middle East in H223, with marketing authorisations granted in four countries, including the UAE.
  • Futura Medical has MED3000 production rights, receiving an agreed price for manufacture and supply. The contract manufacturing supply chain is ready for commercial production and has sufficient capacity in place for the expected commercial demand. The first production orders for launch stocks have been successfully completed. Additional manufacturers in both Europe and the US are being evaluated to provide additional capacity.

Trinity Delta view: Futura Medical is set for a pivotal 2023. FDA clearance, which is anticipated in Q223, would position MED3000 as the first OTC (over-the-counter, ie without a doctor’s prescription) clinically proven treatment for ED in the US. A commercial partner for the important US market will be key, hence it is highly encouraging that several discussions are active and ongoing. With partners already secured for multiple major ex-US markets and first launches in progress, commercial momentum is growing. As we have noted previously, the market opportunity for MED3000 given the differentiated and rapid onset of action (ahead of typical oral PDE5 treatments) could be significant, and the US opportunity alone more than underpins the current share price. Even modest success in any of the regions targeted for launch would be transformational for Futura Medical. Our valuation is £270m, equivalent to 94p per share.


5 April 2023

Market Cap£132.25m
Primary exchangeAIM
Company CodeFUM
Corporate clientYes

Company description

Futura Medical is an R&D driven small pharma company, with a novel DermaSys transdermal delivery platform. The lead programme, a topically applied gel (MED3000), has been approved as an OTC product for ED (erectile dysfunction) in Europe, and is under FDA review in the US.


Lala Gregorek
+44 (0) 20 3637 5043

Philippa Gardner
+44 (0) 20 3637 5042


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