Trinity Delta MED3000 continues to progress towards first sales

MED3000 continues to progress towards first sales

Lighthouse | 13 December 2022

Share this note

Futura Medical’s business update signals continued progress of MED3000 towards commercialisation and potential first sales in 2023. In the key region of the US, the regulatory process continues to advance and MED3000 is now under formal FDA review following filing as a De Novo medical device in October 2022. The FDA has indicated that the regulatory dossier has passed the initial technical screening. The dossier includes the highly positive data from FM71, the longer-term 24-week study, and from FM57, the 12-week trial. Based on progress and published FDA timelines, granting of marketing authorisation in the US continues to be expected by the end of Q123.
The search for a US commercial partner is underway, which was initiated following FDA filing. The business update highlights that a number of discussions are now ongoing. Meanwhile in Europe, initial launches remain on track for H123 with partner Cooper Consumer Health. The deal with Cooper was agreed in H122 and first orders from Cooper have already been received. Futura Medical has an external third-party contract manufacturer in place for commercial production, with capacity that should be sufficient to meet initial demand and beyond.
First marketing authorisations have now also been granted for Eroxon (MED3000) in three countries in the Middle East, including the United Arab Emirates. Further approvals and initial launches are expected in the Middle East in 2023. Futura Medical executed a deal in this region with Labatec Pharma in September 2021 which covers the Gulf countries (Saudi Arabia, United Arab Emirates, Kuwait, Qatar, Oman, and Bahrain) as well as Jordan, Lebanon and Iraq. The deal includes milestones on regulatory approvals. Futura Medical will provide finished product, from its contract manufacturer, for an agreed price and will also receive royalties on net sales; first production orders have been agreed with partner Labatec Pharma.

Trinity Delta view: 2023 is set to be a pivotal year for Futura Medical, with first potential launches of MED3000/Eroxon. These include in the key regions of Europe during H123, and in the US, once marketing authorisation has been granted; this continues to be expected by end-Q123. US commercialisation will be dependent on securing a partner, and it is encouraging that discussions are ongoing. First approvals in the Middle East is a positive step towards broadening Eroxon’s reach, although we continue to see the biggest potential for MED3000 in the US and in Europe, as outlined in our November 2022 Update. Successful commercialisation in either of these territories could transform Futura Medical, in our view. The market opportunity as the first clinically proven erectile dysfunction (ED) treatment available OTC (over-the-counter) and with a differentiated and rapid onset of action (ahead of typical oral PDE5 treatments) could be significant. Our Futura Medical valuation is £270m, equivalent to 94p per share, with the US opportunity alone more than underpinning the current share price.

Lighthouse

13 December 2022


Price	47.97p
Market Cap	£138.2m
Primary exchange	AIM
Sector	Healthcare
Company Code	FUM

Corporate client	Yes

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.

Analysts

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

Philippa Gardner
pgardner@trinitydelta.org
+44 (0) 20 3637 5042

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.