REG - Futura Medical PLC - Full Year Results ended 31 December 2022

Futura MedicalAnnouncement

05/04/2023 07:15

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RNS Number : 3928V  Futura Medical PLC  05 April 2023

5 April 2023

 Futura Medical plc

("Futura" or the "Company")

 

Full Year Results for the year ended 31 December 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 audited results for the year ended 31 December 2022.

 

Operational Highlights

 

MED3000 - Regulatory

·   Europe: MED3000, brand name Eroxon® is the first pan-European topical
treatment for erectile dysfunction ("ED") available without the need of a
doctor's prescription and available over the counter ("OTC").

Ø In April 2022, Futura received approval for a UKCA mark for Eroxon®,
supplementing the CE Mark approval received in April 2021.

·   USA: 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.

Ø 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.

Ø In October 2022, Futura filed a regulatory dossier with the US Food and
Drug Administration ("FDA"), for marketing authorisation for MED3000 as De
Novo Medical Device - with the potential to be the first major ED treatment
available OTC in the USA.

·   Middle East: In December 2022, Futura announced that MED3000 had
received marketing authorisation in three Middle Eastern countries including
the United Arab Emirates ("UAE").

 

MED3000 - Commercialisation and Manufacturing

·   Futura signed multiple commercial agreements across key markets.

Ø In March 2022, Futura 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.

Ø In May 2022, Futura entered into an exclusive licensing agreement with
Cooper Consumer Health ("Cooper") for the rights to commercialise Eroxon®
throughout the European Economic Area, the United Kingdom and Switzerland.

Ø In December 2022 Futura formally commenced the search for a US partner
ahead of planned FDA approval and continues to be engaged in several ongoing
discussions.

Ø Futura's contract manufacturing supply chain is now ready for commercial
production, with capacity for initial launch supplies of Eroxon® and beyond.

Ø In September 2022, the first production order of Eroxon® was received to
fulfil initial launches through Futura's European and UK distribution partner.

Ø First production orders for initial launches of Eroxon® in the Middle
East, which are planned for 2023, were also received from its Middle Eastern
distribution partner.

·  In Q2 2022, as part of its overall IP protection strategy, Futura filed
national patent applications considered necessary to protect the commercial
interests of MED3000 in line with normal PCT filing procedures in all key ED
markets. If successful, this will provide patent protection until 2040.

 

MED3000 - Environmental awareness and education

·  In October 2022, Futura attended the joint meeting of the Sexual Medicine
Society of North America and the International Society of Sexual Medicine in
Miami.

Ø An Advisory Panel meeting comprised of eight world renowned experts
discussed MED3000's clinical data, its unique mode of action and how it could
be used as a treatment alternative for ED. This panel acknowledged MED3000 as
a potential, safe, fast-acting and effective treatment for addressing the
medical unmet need of many men with ED without the requirement for a doctor's
prescription.

 

Post period Highlights

·   Formal production batches of Eroxon® successfully completed and
initial retail and online launches of Eroxon® in Europe have now commenced
with further manufacturing orders received.

·  MED3000 has been granted initial marketing authorisation in the Middle
East, which now covers four Middle Eastern countries including the UAE.
Further approvals are expected in 2023 alongside initial launches, where
regulatory approval has been received, under the Eroxon® brand.

·  In February 2023, Futura presented MED3000 data in a Poster presentation
at the European Society for Sexual Medicine Congress in Rotterdam.

Ø The Poster presented the positive FM71 Phase 3 study results, announced in
August 2022.

Ø There was an Eroxon® stand at the congress where good interest was
received from congress attendees who welcomed the new innovation in ED.

·  In March 2023, Futura announced that MED3000 was under active review with
the FDA, including a recent meeting, regarding US marketing authorisation. As
a regular part of its review process, the FDA asked some additional questions
and requested some non-clinical confirmatory data, to which the Company has
provided a full response and the requested confirmatory data to enable the FDA
to complete its review. Based on the FDA's published target review period
guidelines to include time to review the newly provided information, grant of
the De Novo request is now expected to be achieved in Q2 2023.

 

Financial Highlights

·   Net loss of £5.85 million in period of which £4.13 million was
related to R&D (2021: Net loss £4.96 million)

·   Cash resources of £4.03 million including

·   £1.02 million tax credit refund due mid 2023

·  Current cash runway extends beyond initial Eroxon® launches expected
over the next year and expected US regulatory approval in 2023.

 

James Barder, Chief Executive Officer, Futura Medical said: "2022 has been a
year of significant progress as we have moved steadily towards the initial
launch of Eroxon® which I am now delighted to say commenced in March 2023.
This is a milestone achievement for the Company and a testimony to the
dedication, tenacity and hard work of a small, loyal and highly professional
team at Futura. We are proud and excited for Eroxon® to have now commenced
launch for what we believe will become the world's first fast-acting
clinically proven topical gel treatment for ED available without the need of a
doctor's prescription.

 

We continue to focus on achieving US regulatory approval in the near term and
progressing commercial discussions. We look forward to updating shareholders
during 2023 as well as reporting first meaningful revenues at our interims in
September 2023."

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 10.00am BST on 5
April 2023.

 

For further information please contact:

 

Futura Medical plc

James Barder, Chief Executive Officer

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

Tel: +44 (0) 20 3100 2000

 

For media enquiries please contact:

 

Optimum Strategic Communications

Mary Clark/ Hollie Vile/ Jonathan Edwards/ 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 novel treatment for
erectile dysfunction ("ED") through a unique evaporative mode of action.
Futura has previously conducted an initial Phase 3 study using MED3000 in ED,
referred to as "FM57" which enabled Futura to be granted a CE Mark in 2021. A
second confirmatory Phase 3 clinical study, "FM71" was also conducted to
support Futura's regulatory submission to the FDA with 96 ED patients and
endpoints at 24 weeks, demonstrating 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.

Eroxon® is CE marked in Europe and UKCA 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". Eroxon® is the agreed brand name in certain regions such
as the EU whereas MED3000 continues to be the internal code name used by the
Company and also in reference to countries where regulatory approval or
commercial distribution agreements have not yet been achieved. www.eroxon.com
(http://www.eroxon.com)

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/)

Chairman's Statement

With initial commercialisation now underway, our focus remains on execution in
an exciting market segment.

Futura continues to transform into a potentially high growth Company now in
commercialisation phase and poised for first reported revenues in 2023.

 

In 2021 we expanded the Board's international commercial consumer expertise
with the appointment of Jeff Needham and Andrew Unitt as Board Directors. They
have, in conjunction with the entire Futura team, brought their considerable
OTC market expertise and exceptional skills in strategic development and
business management to bear in a multitude of ways. This covers the full
breadth of activities that go hand in hand with the launch of an exciting and
innovative product such as: working with and supporting partners' marketing,
patient and physician awareness and education efforts, ensuring seamless
manufacturing and supply with an eye on future demand for Eroxon®/MED3000 and
a focus on commercial partnering, particularly in terms of first gaining FDA
approval and then leveraging this de-risking event to optimise a US partnering
deal.

 

The USA is the biggest potential OTC market for ED treatments, and we are
committed to achieving success there, particularly with an innovative product
that has demonstrated the ideal characteristics for an OTC treatment and a
rapid speed of onset which could vastly improve access to treatment for the 22
million men suffering from ED(1), particularly with mild to moderate ED.
Whilst some hurdles still exist with regards to the US FDA granting marketing
authorisation and Eroxon® launching commercially in the US, we are confident
that we will be able to successfully execute on the strategic objectives and
make Eroxon® available to consumers.

2022 was a busy year for execution. I would like to thank Futura's
shareholders for their continued support and Futura's employees for their
unstinting efforts in driving forward the progress of the Company.

 

John Clarke

Non-executive Chairman

Chief Executive Officer's Review

A year of regulatory progress and commercial activities for MED3000, as we
prepared for initial launches of Eroxon® which commenced in March 2023.

 

2022 has been another strong year, building on the transformational progress
and momentum achieved during 2021. The two major highlights were our
partnering deal for the commercialisation of Eroxon® in the EEA, the UK and
Switzerland with Cooper Consumer Health, ("Cooper"), a leading European
independent self-care organisation, and delivering highly positive data from
the confirmatory "FM71" Phase 3 study of MED3000 in ED.

 

In May 2022 we were excited to announce the exclusive licensing agreement with
Cooper, for the rights to commercialise Eroxon® throughout the European
Economic Area ("EEA"), the United Kingdom ("UK") and Switzerland. As part of
our close strategic partnership and in line with our expectations we are
pleased to confirm that from 1 April 2023 Eroxon® became available in our
first market in "bricks and mortar" stores and retail pharmacies, supported by
marketing and advertising with a second launch to follow shortly. Eroxon® is
also available online throughout Europe.

 

As the retail roll-out around Europe continues and gains momentum, we will
provide high level updates but would like to remind our shareholders that for
commercial reasons our distribution partners may ask us not to disclose launch
timings and some learnings from individual markets. However, we look forward
to reporting revenues for the first time with our interim results in September
2023.

 

Futura now has a strong and expanding distribution platform in place for
regions outside the key US market. Having signed two commercial agreements in
2022, adding to those from 2021, Futura now has licensing agreements in place
in key markets throughout the EEA, the UK, Switzerland, the Gulf Co-operation
Council (GCC) region, Latin America and South Korea.

 

As announced in September 2022, Co-High Investment Management Limited, has
been unable to deliver on the key development and regulatory milestones
previously set out in the agreement which both companies entered into in March
2021 and matters have not progressed. As the awareness of MED3000 spreads
within the pharmaceutical industry we continue to receive growing interest
from a number of other potential parties for the commercialisation of MED3000
in South East Asia, including China as well as other countries where MED3000
is not yet out-licensed. Our priority remains the US OTC market, as the
biggest potential OTC ED market in the world, nevertheless discussions are
also ongoing elsewhere and we look forward to providing shareholders with
updates in due course.

 

Marketing authorisation has now been received in four Middle Eastern countries
and initial launches are now planned in the Middle East in the second half of
2023. Our partners are taking a measured and controlled approach, which we
fully endorse, in launching this new product, and there will undoubtedly be
some learnings given the sensitivities around the need for, and purchasing of,
an ED treatment. We must be mindful of these to ensure we position Eroxon® in
the most appropriate way in different countries and diverse cultures, as this
will enable us to maximise the success of future launches of such a truly
innovative and accessible product.

 

With regards to manufacturing, the first production runs of Eroxon® have been
completed and have been successfully delivered, enabling initial launches as
planned. In addition, a number of other orders are in the process of being
manufactured. It is essential that Futura has a robust supply chain, and we
are currently evaluating additional manufacturers in both Europe and the USA
to provide greater supply certainty and inter-manufacturer competition, as
well as additional capacity based on both Futura and commercial partners'
sales projections moving forwards.

 

As the initial launches and strategic scale-up of commercialisation of
Eroxon® continue in 2023, we hope to be able to transform the lives of ED
sufferers around the world with our novel fast-acting OTC treatment.

 

Results from the "FM71" study were in line with data generated in the previous
1,000 patient, "FM57" Phase 3 clinical study and broadly comparable with data
from a "real world" home use study conducted by one of Futura's distribution
partners. Safety and tolerability data were highly positive, with no serious
adverse events recorded in any subjects on MED3000 and overall, a highly
favourable side effects profile. All primary and secondary endpoints were
achieved at 24 weeks, notably showing a clinically important improvement in
erectile function across mild, moderate and severe ED sufferers, as well as
statistically significant improvement in erectile function compared to
baseline. Furthermore, a secondary endpoint showing a 10-minute onset of
action was met, demonstrably faster than the well-known US prescription oral
medication used in a comparator treatment arm of the study.

 

Accumulated MED3000 clinical data demonstrates that the product presents an
effective treatment option with a rapid onset of action and a favourable risk
versus benefit profile ideally suited to men with mild to moderate ED. MED3000
is expected to provide an alternative to existing ED treatments, that require
a doctor's prescription, for those men seeking fewer systemic side-effects,
and a spontaneous intercourse experience.

 

Data from this confirmatory clinical study, FM71, alongside additional data
from FM57, supports the US regulatory submission for MED3000 as a medical
device for ED treatment. In March 2023, Futura announced that MED3000 was
under active review with the FDA, including a recent meeting, regarding US
marketing authorisation. As a regular part of its review process, the FDA
asked some additional questions and requested some non-clinical confirmatory
data to which the Company has provided a full response and the requested
confirmatory data to enable the FDA to complete its review. Based on the FDA's
published target review period guidelines to include time to review the newly
provided information, grant of the De Novo request is now expected to be
achieved in Q2 2023.

 

Achieving FDA approval remains a critical focus as it will significantly
de-risk MED3000 and optimise the negotiating position as discussions regarding
US commercialisation rights progress.

 

In early 2023, Futura personnel, alongside representatives from our commercial
partners, attended the European Society for Sexual Medicine Congress in
Rotterdam where we presented clinical data on MED3000. We co-hosted an
Eroxon® stand and were pleased with the positive interest from congress
attendees who welcomed the new innovation in ED. It is an exciting prospect
that we are bringing a truly unique and differentiated treatment option to the
market.

 

The Company is currently fully focused on achieving MED3000 FDA approval and
US launch, however post approval, our attention will move towards the next
stage of innovation as we look to extend the Eroxon® pipeline and grow the
business further.

 

2023 is going to be an exciting and pivotal year for the Company, with several
further significant milestones expected, including first reported revenues and
we look forward to providing further updates to shareholders as Eroxon® is
launched in a growing number of countries and we continue to sign further
commercial agreements and expand our business globally.

James Barder

 

Chief Executive Officer

On behalf of the Board

 

Operational Review

 

DermaSys(®) - Futura Medical's innovative, 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 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 - Futura's novel, fast acting topical gel formulation for the
treatment of Erectile Dysfunction ("ED")

 

MED3000 is CE marked in Europe and UKCA 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
physical evaporative mode of action which the Company believes stimulates
nerve endings in the glans penis to cause an erection.

 

Faster than on-demand oral tablet phosphodiesterase-5 inhibitors ("PDE5i's" -
oral treatments for the treatment of ED such as Viagra®, Levitra ® and
Cialis ® and their generic equivalents), MED3000 has significant benefits
allowing spontaneous rather than pre-planned sexual intercourse.

 

The prevalence of ED disrupts the lives of at least 1 in 5 men globally(2)
with around 22 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 and
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 PDE5i's is driving volumes, especially in
the USA which has increased by 85% between 2018 and 2020(3).

 

US market research conducted in 2022 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(4). This reconfirms the significant opportunity that MED3000
represents with OTC availability.

 

Futura's objective of OTC status as a clinically proven treatment for ED for
MED3000, particularly in the USA, continues to be a top priority given the
limited availability of OTC PDE5i's around the world.

 

In January 2022 BfArM's (the Federal Institute for Drugs and Medical Devices
in Germany) Expert Committee for Prescription rejected the prescription to OTC
reclassification of sildenafil (50mg) for oral use to treat ED. Sildenafil
currently has OTC status only in Ireland, New Zealand, Norway, Poland, and the
UK.

 

In March 2022, the Office for Registration of Medicinal Products, Medical
Devices and Biocidal Products approved the prescription to OTC
reclassification of Adamed Pharma's Tadalafil Maxon (10 mg) in Poland.
Similarly, a proposal for OTC availability of Tadalafil 10 mg is believed to
be under consideration by the Medicines and Healthcare products Regulatory
Agency ("MHRA"), in the UK.

 

Continuing regulatory and commercial progress for MED3000

 

CE marked as Class 2 medical device from the EU Notified Body and UKCA marked
(following Brexit), Futura's novel, fast-acting topical gel formulation
MED3000, is the first clinically proven topical treatment for adult men with
ED available without a doctor's prescription that helps men get an erection
within 10 minutes.

 

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.

 

USA - the largest potential OTC ED market globally

 

In October 2022, Futura filed an application for Marketing Authorization as a
De Novo Medical Device, presenting the case that MED3000 is 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.
This followed positive results achieved in the FDA required, confirmatory,
Phase 3 clinical trial, FM71, designed to provide supplementary efficacy data
to the previously reported Phase 3 clinical study FM57.

 

The submission of the marketing application has opened the pathway for
commercialisation of MED3000 in the USA, the biggest potential OTC ED market
worldwide, with our key differentiator of a clinically proven treatment for ED
with a rapid speed of onset.

 

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

 

In August 2022, Futura announced positive results from FM71, in line with data
generated in FM57 and broadly comparable with a recent "real world", home use
study conducted by one of Futura's distribution partners.

 

FM71 was a multi-centre, randomised, open-label, home use, parallel group,
clinical investigation of MED3000 compared to a well-known US prescription
oral medication. 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 in 96 male subjects
 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.

 

MED3000 has the opportunity to provide an alternative option to existing ED
treatments, that require a doctor's prescription, for those patients seeking
fewer systemic side-effects, and a spontaneous intercourse experience. It also
provides an important treatment option for those patients who are currently
precluded from using current prescription treatments such as those men taking
nitrate medication.

 

FM71 also included pre-agreed FDA criteria for proving a rapid onset of
action. Data demonstrated a highly statistically significant improvement,
P<0.001, at 10 minutes where subjects noticed an erection. The comparator
product, a well-known US prescription oral medication, did not meet the
criteria at the same time point. Oral "on demand" tablets typically take 30-60
minutes to work and therefore a claim regarding MED3000's rapid onset of
action represents a significant advancement in therapy over existing oral on
demand treatments.

 

USA Regulatory status

Following the successful FM71 study results, Futura filed an application for
Marketing Authorization of MED3000 as a De Novo Medical Device, presenting the
case that MED3000 is an effective clinically proven treatment for ED with a
rapid onset of action and a favourable benefit versus risk profile ideally
suited for OTC classification, without the need for a doctor's prescription.

 

The FDA has now confirmed that the dossier is under formal review having
passed the initial technical screen, and the application is now undergoing
further review. In March 2023, Futura announced that MED3000 was under active
review with the FDA, including a recent meeting, regarding US marketing
authorisation. As a regular part of its review process, the FDA asked some
additional questions and requested some non-clinical confirmatory data to
which the Company has provided a full response and the requested confirmatory
data to enable the FDA to complete their review. Based on the FDA's published
target review period guidelines to include time to review the newly provided
information, grant of the De Novo request is now expected to be achieved in Q2
2023.

 

In anticipation of FDA approval, Futura is actively seeking a US commercial
partner and is engaged in several ongoing active discussions. Further updates
will be provided in due course.

 

MED3000 - Commercialisation and launch plans

 

Multiple commercial agreements in key markets

 

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

 

With multiple commercial agreements in key markets, Futura is continuing to
expand its strong network of licensing and distribution partners and initial
launches have commenced under the brand name Eroxon® in March 2023 with
further launches planned through the remainder of 2023 and beyond.

 

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

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 EEA, the UK and Switzerland. Under the
terms of the agreement, Futura received an initial upfront payment, and will
receive undisclosed cumulative sales milestone payments. The agreement is for
an initial term of five years complying with EU competition law.

 

Futura will remain legal manufacturer and will be responsible for the supply
of MED3000, through its third-party contract manufacturers.

 

South Korea - Menarini Korea Limited ("Menarini 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 received an upfront
payment and will supply MED3000 from Futura's third party contract
manufacturers. Menarini is now in discussions with the Korean regulator
relating to the marketing authorisation of Eroxon®.

 

Gulf Co-operation Council ("GCC") region and Middle East - Labatec Pharma
("Labatec")

Swiss-based specialty pharma company Labatec has the rights to exclusively
commercialise MED3000 in the GCC region as well as Jordan, Lebanon and Iraq.
The initial licence agreement term is for eight years with the ability to
extend for successive two-year terms by mutual consent.

 

Brazil and Mexico - m8 Pharmaceuticals Inc ("m8")

Specialty biopharmaceutical company m8 has the rights to exclusively develop
and commercialise MED3000, in Brazil and Mexico, the two biggest countries and
healthcare markets in Latin America. The agreement is for an initial term of
15 years. m8 will be responsible for all costs related to the regulatory
approval and marketing of the product. Futura will provide reasonable ongoing
technical support for OTC product development and commercialisation.

 

China and South East Asia

As previously referenced, our prospective Chinese commercial partner, Co-high
is unable to deliver on key development and regulatory milestones previously
set out in the agreement which was announced in March 2021. Futura is
continuing to explore alternative options and has received interest from
several potential parties for the commercialisation of MED3000 in South East
Asia including China. South East Asia and China remain a significant
commercial opportunity, although further clinical trials will be required, as
previously disclosed.

 

USA commercialisation strategy

In line with the Board's US commercialisation strategy, following the
successful completion of FM71 and the FDA dossier submission completed in
October 2022, Futura commenced the search for a US commercial partner through
its specialist corporate advisors. Futura has also received a number of
enquiries regarding commercialisation opportunities for MED3000 for the key US
market, and the Board, along with its advisors, is focused on securing the
best options in order to maximise long-term value and sustainable revenues,
whilst minimising risk for Futura's shareholders.

 

Manufacturing

 

Manufacturing scale up was completed in H2 2022 with sufficient production
capacity on-stream to meet projected initial demand and beyond. First
commercial manufacturing orders have been received. Options for additional
manufacturing sites to increase supply chain robustness continue to progress.
MED3000 supply is ISO 13485 accredited with a competitive cost of goods and
has an approved 42-month shelf-life in Europe, 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, in particular MED3000. The Company continues to work with specialist
patent and trademark advisors to further refine and optimise this strategy. 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.

 

Education and outreach on erectile dysfunction and MED3000

 

In October 2022, Futura held an Advisory Panel meeting at the Sexual
Medicine Society of North America ("SMSNA") in Miami, USA. The Panel was
comprised of eight world renowned experts in Sexual Medicine from
the USA, Europe, UK and Brazil who convened to discuss MED3000's
clinical data, its unique mode of action and how it could be used as a
treatment alternative for ED. MED3000 was acknowledged by the Advisory
Panel as a potentially safe, fast-acting and effective treatment for
addressing the unmet medical  need of ED via OTC. Two members of the
Panel, Professor Hellstrom and Dr Glina recorded their specific thoughts
on how MED3000 might be of benefit to patients. The video can be accessed via
the Futura Medical website www.futuramedical.com.

 

In February 2023, Futura presented clinical data on MED3000 as part of a
Poster presentation at the European Society for Sexual Medicine ("ESSM")
Congress in Rotterdam, highlighting the recent, confirmatory FM71 Phase 3
study results. The Company co-hosted an Eroxon® booth with its distribution
partners and received strong interest from a number of congress attendees who
welcomed the new innovation in the ED sector.

 

Futura is delighted with the feedback from attendees, which very much echoed
the sentiment seen at the 2022 advisory meeting.

 

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 DermaSys(®) formulated products.

 

Whereas Futura's priority remains the approval and subsequent successful
launch of MED3000 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 OTC products.

 

Outlook

 

Futura is pleased and excited by the progress made in accomplishing its
strategic objective of creating a global network of 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 delighted that the initial launch of MED3000 under the brand name
Eroxon® has recently commenced and look forward to further launches through
our distribution partners as soon as practicable after regulatory approval
allows.

 

We are also firmly focused on gaining marketing authorisation in the key
market of the USA in the near term to enable the marketing of MED3000 as a
clinically proven topical treatment for ED with a rapid speed of onset and
without the need for a doctor's prescription.

 

Thank you for your continued support of Futura Medical.

 

1.    2021 JSB Partners estimate based on US Census International Programs
Population by age groups and "Prevalence of erectile dysfunction:
Massachusetts Male Aging Study", 1987 ± 1989; source Kleinman et al. J Clin
Epidemiol 2000.

2.      EMA, Withdrawal assessment report for Viagra, 2008

3.      Manufacturers' Selling Prices, IQVIA 2020 market data

4.      Ipsos research commissioned by Futura, 2022

Financial Review

 

As outlined in the Chairman's Statement and Chief Executive's Review, Futura
continued to focus its financial resources on MED3000, its fast-acting gel
treatment for erectile dysfunction ("ED") concentrating on the US path to
regulatory submission, and enabling commercialisation through securing
licensing and distribution deals with commercial partners to build and grow a
worldwide distribution and marketing network.

 

In 2022, the Company entered into licensing agreements with Menarini Korea for
exclusive rights to commercialise MED3000 in South Korea and with Cooper
Consumer Health for rights throughout the European Economic Area, the United
Kingdom and Switzerland. First orders were received from Cooper Consumer
Health to fulfil initial launches.

 

Following highly positive results from the FM71 Phase 3 clinical study, the
Company filed a regulatory dossier with the US FDA in October 2022 and also
formally commenced the search for a US partner ahead of the planned approval
in 2023.

 

Revenue

Initial orders for Eroxon® were received during the year with delivery
anticipated early 2023. No revenue was recognised in the period (please see
Note 2.4 for more information).

 

Research and Development costs

Research and Development (R&D) costs for the period ended 31 December 2022
were £4.13 million, compared to £3.77 million for the period ended 31
December 2021. The increase of £0.36 million reflects the completion of the
FM71 study and continuing manufacturing scale-up activities ahead of
anticipated Eroxon® launches.

 

There was no capitalisation of R&D costs in 2022. (2021: nil)

 

Administrative costs

Administrative costs were £2.74 million for the period ended 31 December 2022
compared to £2.09 million for the period ended 31 December 2021. This is an
increase on the prior year and partly driven by higher costs associated with
supporting commercial partners and supply chain activities in readiness for
launching Eroxon® over the next year. In addition, there were some one-off
costs incurred relating to fees associated with negotiating and concluding
commercial arrangements for MED3000.

 

Tax

It is expected that an R&D tax credit of £1.02 million will be claimed in
respect of 2022 and the cash refund is expected to be received mid-2023 from
HMRC.

 

Loss per share

The basic loss per share for 2022 was 2.03p (2021: 1.83p). Details of the loss
per share calculations are provided in Note 10 to the Preliminary Results.

 

Cash balance

The cash balance at the end of 2022 was £4.03 million (2021: £10.37
million). Cash burn during the year was £6.34 million (2021: £4.39 million)
primarily in relation to the completion of the FM71 clinical study,
manufacturing capital equipment and scale-up activities associated with
MED3000. Other one-off costs associated with the conclusion of commercial
agreements with MED3000 licensing and distribution partners were also
incurred.

 

Current cash runway extends beyond initial Eroxon® launches expected over the
next year and expected US regulatory approval in 2023, assuming conservative
revenues are received from existing launches.

 

Going Concern

The Board has considered the applicability of the going concern basis in the
preparation of the financial statements. Notwithstanding a loss for the year
ended 31 December 2022 of £5,846,495, the Board considers that, based on the
reasons set out in Note 2.2 of the Preliminary Results, the preparation of the
financial statements on a going concern basis remains appropriate. However, it
also acknowledges that a material uncertainty exists that may cast significant
doubt on the Group's ability to generate sufficient net revenues and raise
sufficient finance to meet its expected costs and to continue as a going
concern and to realise its assets and discharge its liabilities in the normal
course of business.

 

The auditor's report includes reference to the material uncertainty relating
to going concern. Further information in relation to going concern can be
found in Note 2.2 of the Preliminary Results.

 

Angela Hildreth

Finance Director and Chief Operating Officer

 

Preliminary Results
- http://www.rns-pdf.londonstockexchange.com/rns/3928V_1-2023-4-4.pdf
(http://www.rns-pdf.londonstockexchange.com/rns/3928V_1-2023-4-4.pdf) to view
Futura Medical's Preliminary Results

 

 

 

 

 

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