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Futura Medical shares up over 250% YTD: is there more to come?

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In biotech, nothing boosts your share price like obtaining regulatory approval for your products. Futura Medical (LSE:FUM) shares jumped 155% last Friday (19 March) on news that it was to receive EU certification for its MED3000 gel, an erectile dysfunction treatment, as a Class 2B approved medical device.

US FDA approval in the pipeline?

On the following Monday this week (22 March) shares were up a further 100% at 67.60p, when the US Food & Drug Administration agreed to conduct a confirmatory clinical study for the product, granting it the status of a ‘de novo medical device’, which gives it protection against copy-cat rivals.

This isn’t a certification but, if the science is sound, as the EU approval would indicate, then US certification should follow when the FDA study completes in six months’ time. Futura shares are currently trading at 54.00p, with a year-to-date return of 256.4%.


The EU regulatory approval is a significant development on several levels. The EU’s approval, and the resulting CE mark, opens the way for Futura Medical to gain fast-track approval in those countries around the world that recognise the CE mark. Already, Futura has announced (on 3 March) a Joint Collaboration agreement with the Atlantis Group for the China and South East Asia region.

Under the terms of the deal, Atlantis Group will cover all regional MED3000 development and regulatory costs, estimated to be up to £4m, with all regional profits shared on 50:50 basis. Futura Medical has already received £1.5m in cash through the issuance of convertible loan notes with a 3-year conversion period at a premium price of 20p.

It is worth noting that, in Atlantis Group, Futura Medical has secured an important ally for the product’s marketing and distribution in Asia.

Who are Atlantis Group?

Atlantis is a leading international asset management company specialising in the Greater China Region and South East Asia, while its subsidiary Co-High Investment Management is a private equity company focused on the Greater China region that invests into and collaborates with companies that they believe are poised to enter a hypergrowth phase.

James Barder, CEO of Futura, described this regulatory development as a ‘breakthrough’ and said: “This is a huge milestone for Futura in the development of MED3000, and will represent a significant commercial opportunity.” Futura Medical estimates this product could be worth as much as $5.6bn.

With the CE-mark under its belt, Futura Medical can market the MED3000 gel throughout the EU, without any national marketing restrictions, as the first pan-European topical treatment for erectile dysfunction available in Europe. A potential boost for future sales figures is that the product can be bought over the counter, without need for a doctor’s prescription.

For investors, the reason to invest in Futura Medical won’t be found in its balance sheet, which features operating losses (£1.4m) and non-existent earnings. Its interim results for the six months ended 30 June 2020 reported a £1.06m net loss (H1 2019: £4.5m net loss), with a cash position of £2.6m and total net assets of £2.1m. The reason to invest in Futura, now that it has the right ‘breakthrough’ product with the right commercialisation strategy in place, is its potential to finally generate good profits.

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This article does not constitute investment advice. Do your own research or consult a professional advisor.

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