Futura Medical CEO James Barder discusses FDA approval, market share gains, and plans for Eroxon

In an exclusive with Proactive, James Barder, CEO of Futura Medical PLC (AIM:FUM, OTC:FAMDF), discusses the company's remarkable first half of the year, marked by FDA approval for its erectile dysfunction gel, Eroxon. Barder delves into the financial milestones, market share gains, and future expansion plans, painting an optimistic picture for the company's trajectory.

Thomas Warner (TW): Good morning, James Barder. Thank you for joining us today. Let's dive right in. Could you provide our readers with a summary of the first six months for Futura Medical?

James Barder (JB): Certainly. The first half of the year has been quite eventful. We received Food and Drug Administration (FDA) approval for MED3000, which is also known as Eroxon. This was a significant milestone for us. Additionally, we secured a major deal with Halen for the US marketing rights, which has been a game-changer. In the United Kingdom and Belgium, we've launched the product with full advertising and promotion support. The early signs are very encouraging; we've achieved around a 20% market share in the segment of clinically proven erectile dysfunction treatments.

TW: That's quite an achievement. Would you go as far as to say that this has been the best six months in the company's history?

JB: Without a doubt. For the first time in our history, we're reporting revenue—£1.7 million for the first six months. This is particularly significant because we only launched in April. We also generated a gross profit of around £900,000, which translates to a margin of about 50% on sales to date. We're projecting to break even by 2024 and are aiming for profits by 2025.

TW: That's promising. Now, are there any challenges or potential pitfalls that you're keeping an eye on?

JB: One of the key challenges is scaling up production to meet demand. We've already appointed a second manufacturer and are considering adding a third. Another area we're focusing on is distribution, particularly in Asia. We recently terminated a deal with CCO due to performance issues but have received strong interest from other commercial parties.

TW: Could you elaborate a bit more on the market share? How is Eroxon being received in the market?

JB: We estimate that we've captured about 20% of the market for clinically proven erectile dysfunction treatments. What's even more exciting is that these sales are predominantly incremental. This means we're not just taking a slice of the existing market; we're actually growing it. Retailers are particularly happy with the product because it increases footfall without cannibalising existing sales.

TW: That's intriguing. Have you received any feedback from customers?

JB: Yes, we've had very few complaints. Out of the 200,000 packs that have been sold, we've received fewer than 100 complaints. Most of these are related to efficacy, which is understandable given that the product works in about 65% of men. Overall, the product has been well-received.

TW: What are your plans for expanding into other markets, especially considering your success in the UK and Belgium?

JB: We're quite ambitious in that regard. We expect to launch in around 10 more countries in the Middle East and Europe by the end of April next year. We're also focusing on Asia, where we've had strong interest from various commercial parties.

TW: Could you provide more details on the deal with Haleon PLC (LSE:HLN, NYSE:HLN)?

JB: Certainly. Haleon is one of the largest over-the-counter (OTC) brands globally. The deal we've struck grants them the US marketing rights for Eroxon. We've received an initial milestone payment of around US$4 million from Halen, which we expect to account for fully next year.

TW: What about the production side? Are there any bottlenecks or challenges you foresee?

JB: We're working diligently to expand production. We've appointed a second manufacturer and are considering a third to ensure we meet demand, especially as we expand into new markets.

TW: Lastly, what message would you like to convey to your shareholders?

JB: It's been a great six months for Futura Medical. We're in a strong financial position with over £9 million in the account as of the end of August. We're excited about the future and look forward to continued growth and success.