Futura Medical

MED3000 receives CE Mark as a Class II(b) device

Lighthouse | 30 April 2021

Share this note

  • Futura Medical has received the approval certificate for MED3000 from the designated EU Notified Body. The CE Mark as a Class II(b) medical device means MED3000, a proprietary topical gel for erectile dysfunction (ED), the first clinically proven OTC treatment is approved across Europe.
  • The CE Mark is recognised by a number of territories globally, including many countries in Latin America, Middle East and South East Asia, and paves the way for faster market introductions.
  • We have viewed European approval as a prerequisite for the conclusion of commercial partnerships. Management has confirmed that it has received proposals from various potential partners and discussions are believed to be progressing well. We expect the first agreement should be in place within a matter of several months.
  • Manufacturing scale-up is also said to be progressing well, suggesting that the production process will not be a rate-determining step in the launch preparations.
  • The market opportunity for the first clinically proven ED product approved for OTC use could be significant. Its rapid onset of effect, undoubted safety, and ease of use suggest MED3000 would offer an attractive, clearly differentiated (not ‘me too’), and competitive clinical profile compared not only to the market leading class of PDE5 inhibitors, but other classes of competing ED therapies.

Trinity Delta view: Although MED3000’s imminent approval in Europe was flagged in March, the receipt of the official documentation paves the way for commercialisation discussions for a number of geographies to proceed at pace. The timings remain uncertain, but we would expect to see a number of deals in place within the next six months. For these geographies, the key sensitivity shifts from regulatory risk to execution risk, particularly the nature and scope of the commercialisation agreements. Our valuation model employs conservative assumptions and values Futura Medical at £190.3m which, following the full conversion of the loan notes held by HT Riverwood Multi-Growth Fund (Atlantis Group) earlier this month, is equivalent to 74.3p per share.

Lighthouse

30 April 2021

Price45p
Market Cap£115.2m
Primary exchangeAIM
SectorHealthcare
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 in Europe as a medical device for ED (erectile dysfunction), with the US awaiting a final confirmatory study.

Analysts

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

Franc Gregori
fgregori@trinitydelta.org
+44 (0) 20 3637 5041

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.

Copyright 2021 Trinity Delta Research Limited. All rights reserved.