Futura Medical: AGM statement confirms MED3000 filings on track
Futura Medical confirms the timelines for the regulatory filings for MED3000, its novel erectile dysfunction (ED) treatment, are on track. Dialogues with both the US FDA and European Notified Body have been constructive. The EU Notified Body has begun its review of the supporting documentation and the FDA filing is still expected by end-Q320. There have been no COVID-19 related delays but, in our view, these remain a consideration. We assume the review processes will take a minimum of 12 months in both cases, so have approvals pencilled in for Q421. Commercialisation discussions are expected to start in earnest once the status of the regulatory approvals is known. Our DCF-based model, using conservative assumptions, values Futura Medical at £153.8m, equivalent to 60.9p a share.Futura Medical is engaged in the research and development of pharmaceutical drugs and medical devices and their commercial exploitation. Co. focuses on developing products primarily for the consumer healthcare market. Co.'s focus is on sexual healthcare and pain relief. DermaSys® is Co.'s transdermal technology platform, for the absorption of active molecules through the skin. DermaSys® includes MED2002, a topical gel for the treatment of erectile dysfunction; TPR100, a topical diclofenac pain relief gel; TIB200, a topical ibuprofen pain relief gel; and SPR300, a topical methyl salicylate pain relief gel.
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