REG - Futura Medical PLC - Futura Medical Interim Results 2022

Futura MedicalAnnouncement

13/09/2022 07:01

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RNS Number : 1661Z  Futura Medical PLC  13 September 2022

13 September 2022

 Futura Medical plc

("Futura" or the "Company")

 

Interim Results for the Six Months ended 30 June 2022

 

Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio
of innovative products based on its proprietary, transdermal DermaSys® drug
delivery technology and currently focused on sexual health and pain, is
pleased to announce its unaudited interim results for the six months ended 30
June 2022.

 

Operational Highlights

 

MED3000 - Regulatory

·        Europe: MED3000 will be the first pan-European topical
treatment for erectile dysfunction ("ED") available without the need of a
doctor's prescription ("OTC").

o  In April 2022, Futura received approval for a UKCA mark for MED3000,
supplementing the CE Mark approval received in April 2021.

·        US: In August 2022, Futura received highly positive results
from the confirmatory Phase 3 clinical study, ("FM71") for MED3000 for the
treatment of ED meeting all primary and secondary endpoints.

o Results demonstrated that MED3000 presents an effective clinically proven
treatment for ED with a rapid speed of onset and a favourable benefit versus
risk profile ideally suited for OTC classification.

o  Futura expects to file a regulatory dossier with the US Food and Drug
Administration ("FDA") by the end of September 2022, targeting marketing
authorisation for MED3000 in Q1 2023 as the first major ED treatment available
OTC throughout the USA.

 

MED3000 - Commercialisation & Manufacturing

·    Futura has signed multiple commercial agreements to date across key
markets, as it continues to build a strong network of licensing and
distribution partners with strength in brand building, pharmaceutical
credibility and marketing expertise for long-term distribution of MED3000
across the globe.

o  In March 2022, Futura announced that it had entered into a licensing
agreement with Menarini Korea, a wholly owned subsidiary of Menarini Group,
for the exclusive rights to commercialise MED3000 in South Korea.

o  In May 2022, Futura announced an exclusive licensing agreement with Cooper
Consumer Health for the rights to commercialise MED3000 throughout the
European Economic Area, the United Kingdom and Switzerland. Plans are at an
advanced stage for initial launches in first half of 2023.

o  Following successful completion of FM71, Futura's specialist corporate
advisors have now formally commenced the search for a US partner.

·    Through its commercial partners, Futura aims to launch MED3000 and
build a respected, high quality, and trusted global brand. Futura's contract
manufacturing supply chain is now ready for commercial production, with
capacity for initial launch supplies of Eroxon™ and beyond. Eroxon™ has an
approved shelf-life of 42 months which will provide at least 3 years
shelf-life at point of sale. First manufacturing orders have been received
from our European partner.

·    Regulatory approvals for a number of non-EU markets through Futura's
commercial partners are progressing well other than in China where the
regulatory approval for MED3000 remains a number of years away.

·    Futura has recently completed additional national patent applications
in line with normal PCT filing procedure in all key ED markets in order to
protect the commercial interests of MED3000. If national patents applications
are successful, this will provide patent protection until 2040.

 

Board updates

·    Futura strengthened the Board with the appointment of Andrew Unitt,
who was previously Finance director of Boots Healthcare International, as a
non-executive director as of 1 January 2022.

 

Financial Highlights

·    £2.50 million net losses in the period (30 June 2021: net total
loss £1.59 million).

·    Cash resources of £6.68 million at 30 June 2022 (excluding tax
credit due of £0.91 million).

·    Current cash runway extends well beyond expected initial MED3000
launches in the coming months and expected US regulatory approval in Q1 2023.

 

James Barder, Chief Executive Officer, Futura Medical said: "I am delighted
with the significant progress we have made during the first half of the year
as we continue to deliver on the Company's strategic objectives. The whole
team at Futura looks forward with growing excitement to the launch of
Eroxon™ in the coming months as we, in close alignment with our commercial
partners, work hard to build Eroxon™ into a long term, profitable and
trusted brand."

 

Webcast

The Executive Team will host a webcast of the presentation which will be
available within the Investor Centre section of the Futura company website at
www.futuramedical.com (https://www.futuramedical.com/) from 10 am BST on
Tuesday 13(th) September 2022. The Company will provide an update on the
regulatory pathway of MED3000 in the US, manufacturing and commercialisation
progress.

 

For further information please contact:

 

Futura Medical plc

James Barder, Chief Executive

Angela Hildreth, Finance Director and COO

Email: investor.relations@futuramedical.com
(mailto:Investor.relations@futuramedical.com)

Tel: +44 (0) 1483 685 670

www.futuramedical.com (http://www.futuramedical.com/)

Nominated Adviser and Sole Broker:

 

Liberum

Phil Walker/ Richard Lindley/ Ben Cryer/ Kane Collings

Tel: +44 (0) 20 3100 2000

 

For media enquiries please contact:

 

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile/ Zoe Bolt

Email: futuramedical@optimumcomms.com

Tel: +44 (0) 203 882 9621

 

About Futura Medical plc

Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a
portfolio of innovative products based on its proprietary, transdermal
DermaSys® technology. Each DermaSys® formulation is separately patented and
specifically tailored for the selected indication and application, as well as
being optimised for clinical efficacy, safety, administration and patient
convenience. The products are developed for the prescription and consumer
healthcare markets as appropriate. Current therapeutic areas are sexual
health, including erectile dysfunction, and pain relief. Development and
commercialisation strategies are designed to maximise product differentiation
and value creation whilst minimising risk.

 

MED3000 is Futura's topical gel formulation that is a breakthrough treatment
for erectile dysfunction ("ED") through a unique evaporative mode of action.
Futura has previously conducted a Phase 3 study using MED3000 in ED, referred
to as "FM57". This was a 1,000 patient, dose-ranging, multi-centre,
randomised, double blind, placebo-controlled, home use, parallel group study
delivering highly statistically significant results compared to pre-treatment
baseline, using measures IIEF-EF, SEP2 and SEP3 (internationally accepted
clinical trial endpoints in ED) with over 60% of patients experiencing a
clinically meaningful improvement in their ED.

 

MED3000 is CE marked in Europe and CA marked in the UK as a clinically
proven topical treatment for adult men with erectile dysfunction under the
brand Eroxon™ with a key claim of "Helps you get an erection within 10
minutes".

 

Futura is based in Guildford, Surrey, and its shares trade on the AIM market
of the London Stock Exchange.  www.futuramedical.com
(http://www.futuramedical.com)

 

Operational Review

 

DermaSys(®) - Our proprietary patented transdermal technology platform

 

Futura's unique patented technology DermaSys(®) is designed to deliver
clinically proven effective medical treatments via the skin.

 

DermaSys(®) is a versatile and bespoke technology. Each product gel is
uniquely formulated using the DermaSys(®) platform with volatile solvent
component formulations tailored for each product to suit the specific
therapeutic indication and desired speed of onset and duration of action. Such
targeted delivery offers an optimised profile in terms of dose, onset time and
duration of effect as well as an improved safety profile reducing the risk of
side effects. Each product is formulated to maximise its benefits for patients
and consumers. Each new unique formulation offers the opportunity for
additional patent applications and potential patent protection.

 

MED3000 - breakthrough, fast acting topical gel formulation for the treatment
of Erectile Dysfunction ("ED")

 

MED3000 is CE marked in Europe and CA marked in the UK, as a clinically
proven topical treatment for adult men with ED that helps men get an erection
within 10 minutes.

 

Studies have shown MED3000 to be an effective treatment for ED with an
excellent safety profile. MED3000 has a unique evaporative mode of action
which the Company believes stimulates nerve endings in the glans penis to
cause an erection.

 

MED3000 helps men get an erection within 10 minutes, faster than on-demand
oral tablet phosphodiesterase-5 inhibitors ("PDE5is" - oral treatments for the
treatment of ED such as Viagra® Levitra ® and Cialis ® and their generic
equivalents), with significant benefits for spontaneous rather than
pre-planned sexual intercourse.

 

The prevalence of ED disrupts the lives of at least 1 in 5 men globally with
around 23 million men suffering ED in the US and 20 million men in the UK,
France, Italy, Spain and Germany(1). There has been little innovation in ED
treatments for nearly two decades and many patients continue to suffer
dissatisfaction with existing treatments. The US market, in particular,
continues to evolve following the expiry of the PDE5i's patent protection with
the advent of subscription services such as For Hims and Go Roman which offer
a branded concierge service for ED prescription medicines online. This
increased affordability of generic PDE5is is driving volumes especially in the
US which have increased by 85% between 2018 and 2020(2).

 

Recent US market research conducted by IPSOS and commissioned by Futura has
confirmed that even with increasing volumes the requirement of a doctor's
prescription remains both an economic and emotional barrier to use: US
patients spend between US$600 and US$3,500 per annum on ED treatments, when
taking into account both prescription costs and doctors' visits not covered by
insurance(3). This reconfirms the significant opportunity that MED3000
represents with OTC availability at a likely retail price in the region of
US$5 per dose in the USA.

 

MED3000 - approved as the first pan-European topical treatment for ED
available with OTC status

Futura's breakthrough, fast-acting topical gel formulation MED3000, is the
first clinically proven, pan-European topical treatment for adult men with ED
available without a doctor's prescription.

 

In April 2021, the Company received its MDR EU Quality Management Certificate
for the placing on the market of a Class 2B medical device known as MED3000
("CE mark approval").

 

The CE mark approval of MED3000 from the EU Notified Body paves the way for
approval in many countries around the world, including in Latin America, the
Middle East, Africa and the Far East regions, with many countries considering
"fast-track" review based on recognition of the EU CE mark.

 

Due to post-Brexit arrangements, the EU CE mark can be used to market the
product in Great Britain until 30 June 2023 by which time a specific UKCA mark
has to be obtained. In anticipation of this Futura filed for a UKCA mark for
MED3000 as a Class 2A medical device and received approval in April 2022.

 

US - the largest potential OTC ED market globally

In 2020, the FDA agreed that an application may be made for MED3000 as a
medical device for ED treatment, with a De Novo classification. This was
followed by a number of productive and positive pre-submission meetings with
the FDA during 2020 and 2021 to discuss existing Phase 3 clinical data,
pathway to OTC status and any additional clinical and non-clinical
requirements.

 

In 2021 Futura received official minutes from the FDA agreeing the design for
a confirmatory, Phase 3 clinical trial, ("FM71"), designed to provide
supplementary efficacy data to the previously reported Phase 3 clinical study
("FM57") study.

 

FM71 - Highly positive results with all primary and secondary endpoints
achieved

In August 2022, Futura announced positive results from FM71, broadly
comparable with data generated in both FM57 and a recent "real world", home
use study.

 

FM71 was a multi-centre, randomised, open-label, home use, parallel group,
clinical investigation of MED3000 compared to oral tadalafil (5mg) tablets.
The trial design and clinical endpoints were agreed with the FDA and the trial
used gold standard, internationally accepted clinical trial endpoints in ED.

 

FM71 investigated the efficacy and safety of MED3000 gel in 96 male patients
(recruited from the United States (African Americans), Poland, Georgia and
Bulgaria) clinically diagnosed with a mix of mild, moderate and severe ED
against baseline (pre-treatment).

 

FM71 results
(https://polaris.brighterir.com/public/futura_medical/news/rns/story/r79j3zx)
demonstrated that MED3000 presents an effective clinically proven treatment
for ED with a 10-minute onset of action and a favourable benefit versus risk
profile ideally suited for OTC classification.

 

Futura is on track to file a full regulatory dossier with the FDA by the end
of September 2022, targeting marketing authorisation by the FDA of MED3000 in
Q1 2023 as the first major ED treatment available OTC throughout the USA.

 

MED3000 - Commercialisation & Manufacturing

Futura is establishing a network of licensing and distribution partners with
strength in brand building, pharmaceutical credibility and regional
infrastructure and marketing expertise for long-term distribution of MED3000
(Eroxon™) across the globe.

 

With multiple commercial agreements in key markets, Futura now has a strong
and expanding distribution platform in place for regions outside the key US
market.

 

Menarini Korea Limited ("Menarini Korea") - South Korea

In March 2022, Futura announced that it had entered into a licensing agreement
with Menarini Korea, a wholly owned subsidiary of Menarini Group, for the
exclusive rights to commercialise MED3000 in South Korea.

 

Under the terms of the agreement, Menarini will be responsible for all costs
related to the regulatory approval and marketing of the product in the region,
including a clinical bridging study if necessary. Futura will provide
reasonable technical support for product development and commercialisation and
will receive an upfront payment and provide manufactured product from Futura's
3rd party contract manufacturers.

 

Cooper Consumer Health ("Cooper") - European Economic Area, United Kingdom and
Switzerland

In May 2022, Futura announced an exclusive licensing agreement with Cooper, a
leading European independent self-care organisation, for the rights to
commercialise MED3000 throughout the European Economic Area ("EEA"), the
United Kingdom and Switzerland.

 

Under the terms of the agreement, Futura will receive an initial upfront
payment, as well as undisclosed cumulative sales milestone payments and will
manufacture and supply the product (through its 3rd party contract
manufacturers) for the EEA, the United Kingdom and Switzerland to Cooper. The
agreement is for an initial term of five years complying with EU competition
law. Futura will remain Legal Manufacturer(4) and be responsible for the
supply of MED3000 through its 3rd party contract manufacturers.

 

US commercialisation strategy

Following positive FM71 results announced in August 2022, Futura is on track
to file a dossier with the FDA by the end of September 2022, targeting
marketing authorisation by the FDA of MED3000 in Q1 2023 as the first major ED
treatment available OTC throughout the USA.

 

In line with the Board's US commercialisation strategy following the
successful completion of FM71 and expected imminent FDA dossier submission,
Futura has recently commenced the search for a US commercial partner through
its specialist corporate advisors. Futura has already received a number of
inquiries regarding commercialisation opportunities for MED3000 for the key US
market and the Board along with its advisors are focussed on securing the best
options in order to maximise long-term value and sustainable revenues whilst
minimising risk for Futura's shareholders.

 

China and Southeast Asia

The current political environment and restrictive "Zero-Covid" policy in China
has resulted in Co-High Investment Management Limited not being able to
deliver to-date on the key development and regulatory milestones as set out in
the agreement entered into between the companies in March 2021. Futura is
exploring options to remedy this situation in line with the contractual terms
of the agreement as Southeast Asia including China remains a significant
commercial opportunity, although further Phase 3 trials, taking several years,
will be required, as previously disclosed.

 

Manufacturing

The Company engaged a US FDA, EMA and UK approved contract manufacturer in
2021. Manufacturing scale up has now been completed and confirms we have
sufficient production capacity to meet projected initial demand and beyond.
This manufacturer is now ready for commercial production and first
manufacturing orders have been received from Futura's European partner.
Options for the addition of further manufacturing sites to increase supply
chain robustness continue to progress. MED3000 supply is ISO 13485 accredited
with a competitive cost of goods and now has an approved 42-month shelf-life
giving significant distribution flexibility mindful of transport times between
the country of manufacture and final country of sale.

 

Intellectual Property: Patents, Trademarks and exclusively supplied, Critical
Ingredients

Futura's corporate strategy is to develop layers of protection around its
products and in particular MED3000, and the Company continues to work with
specialist patent and trademark advisors to further refine and optimise this
strategy:

 

1.   In line with normal PCT filing procedures MED3000 patents are now filed
in all major ED markets considered necessary to protect the commercial
interests of MED3000. A request to the European Patent Office was made in
August 2021 for examination of the MED3000 patent application and in Q2 2022
it confirmed the novel and inventive nature of the application, which is
required before a patent can be granted, although further review continues.

2.    A key excipient in the MED3000 formulation is made by only one known
manufacturer who has entered into an exclusivity agreement for the supply of
that ingredient (within the sexual health field) for MED3000 manufacturing,
providing further competitive protection around MED3000.

3.   A high-quality dossier that will shortly be submitted to the FDA will
contain substantial safety and effectiveness data. This will be enshrined in
Special Controls(5) which would have to be replicated in full by any potential
competitors hoping to follow the 510K medical device route using MED3000 as
the predicate device to gain FDA marketing authorisation. These controls will
present a formidable barrier to competitor entry to the US market.

4.    Futura aims to work with commercial partners such that MED3000 is
launched, wherever possible, under the Eroxon™ trademark to help establish
global awareness, consumer trust and build worldwide brand integrity. In
consumer health and over-the-counter markets an established brand name is
paramount in providing product price and sales volume stability for many
years.

 

Research and Development

 

Futura is committed to delivering long-term and sustainable value to the
Company allowing a long-lasting growth franchise to be built around MED3000
and other DermaSys(®) formulated products.

 

Whereas Futura's priority remains the approval and subsequent successful
launch of MED3000 (Eroxon™) in major markets throughout the world, Futura
aims to build a significant MED3000 franchise across sexual health by
leveraging and expanding its unique knowledge and expertise in underserved and
new categories in sexual health, building upon market research already
undertaken to identify product extensions and potentially new market segments
for an OTC product treating ED. Futura intends, in due course, to commission
further in-market research, especially for the US, to identify commercially
attractive product line extension opportunities.

 

Board Changes

 

Futura continues to bring new skills and experience to its already highly
skilled Board.

 

In January 2022, Andrew Unitt joined the Company as Non-Executive Director.
Andrew brings strong financial experience having spent eleven years at Boots
plc, where he was Finance Director for four years of Boots Healthcare
International, its over-the-counter medicines business. Andrew's OTC market
expertise and exceptional skills in strategic development and business
management will further enhance Futura's ambition and focus on building a
global brand and distribution network to accelerate Company growth.

 

Andrew chairs the Audit Committee as Jonathan Freeman's successor, following
Jonathan stepping down at the end of 2021.

 

 

Financial Review

 

Research and development costs

Research and development costs for the six months ended 30 June 2022 were
£1.91 million, compared to £1.19 million for the six months ended 30 June
2021 with the increase being predominantly due to increased activity related
to the FM71 study cost.

 

Administrative costs

Administrative costs were £0.94 million for the six months ended 30 June 2022
compared to £0.71 million for the six months ended 30 June 2021. The slight
increase mainly relates to legal and professional costs associated with
concluding MED3000 commercial agreements and supply chain set-up costs.

 

Going concern

At the period end the Group held £6.68 million of cash with a further £0.91
of R&D tax credits relating to 2021 which is expected to be received in
the second half of 2022. The Directors believe that it remains appropriate to
prepare the financial statements on a going concern basis.

 

Cash runway

The Company continues to have sufficient cash resources beyond initial MED3000
launches and expected US regulatory approval. The current runway does not
include any additional revenues from commercial upfront milestones, royalties
or other income generated from MED3000 sales.

 

Outlook

 

Futura is well advanced in its strategic objective of creating a global
network of licensing and distribution partners with strength in brand
building, pharmaceutical credibility, infrastructure and marketing expertise
for long-term profitable distribution of MED3000 across the world.

 

We are looking forward to launching MED3000 as a priority under the Eroxon™
brand with multiple commercial agreements in place in key markets and where
regulatory approval allows.  We are also firmly focussed on gaining marketing
authorisation in the key market of the USA and finalising commercial
arrangements to enable the marketing of MED3000 as a clinically proven topical
treatment for ED with a rapid speed of onset. We look forward to updating
shareholders further on regulatory and commercial progress on MED3000.

 

 

Financial Statements -  see below to view Futura Medical Financial
Statements

http://www.rns-pdf.londonstockexchange.com/rns/1661Z_1-2022-9-12.pdf
(http://www.rns-pdf.londonstockexchange.com/rns/1661Z_1-2022-9-12.pdf)

 

 

1.      EMA, Withdrawal assessment report for Viagra, 2008

2.      Manufacturers' Selling Prices, IQVIA 2020 market data

3.      Ipsos research commissioned by Futura

4.      Legal Manufacture means a natural or legal person who
manufactures or fully refurbishes a device or has a device designed,
manufactured or fully refurbished, and markets that device

5.
www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents

 

 

 

 

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