TIDMFUM
RNS Number : 6621M
Futura Medical PLC
18 September 2023
18 September 2023
Futura Medical plc
("Futura" or the "Company")
Interim Results for the Six Months ended 30 June 2023
Futura Medical plc (AIM: FUM), the pharmaceutical company
developing innovative sexual health products, is pleased to
announce its unaudited interim results for the six months ended 30
June 2023 ("H1 2023").
MED3000, under the brand name Eroxon(R), is the first
pan-European clinically proven topical treatment for Erectile
Dysfunction ("ED") available without the need of a doctor's
prescription ("OTC").
Operational Highlights
MED3000 - Successful product launches and FDA approval
-- EU: Eroxon(R) launched in April 2023 in Belgium and the UK
o Positive launch sales in the UK and Belgium indicate around
20% market share of clinically proven ED treatments.
o Sales predominantly incremental to existing clinically proven
ED treatments highlighting patient demand for Eroxon(R)'s key
product characteristics and supporting the positioning of Eroxon as
a new category.
o Positive initial signs of repeat consumer demand.
-- USA : In June 2023, MED3000 was granted marketing
authorisation by the FDA to be legally marketed in the USA, the
biggest consumer healthcare market globally, as the first
effective, clinically proven OTC treatment for ED.
Financial highlights
-- Initial Revenues generated by sales of Eroxon(R) of GBP1.7 million H1 2023 (H1 2022: nil)
-- Net loss of GBP1.76 million (H1 2022: GBP2.46 million)
-- Cash position at 30 June 2023: GBP7.8 million (30 June 2022: GBP6.68 million)
-- Cash position as at 31 August 2023: GBP9.36 million which
includes $4 million upfront milestone payment from Haleon plc
("Haleon").
Post period highlights
-- USA: Futura e ntered into a ground-breaking licensing
agreement in July 2023 with Haleon, the world leading consumer
healthcare company, for exclusive rights to commercialise MED3000
in the USA.
o Under the agreement, Futura received an upfront payment of $4
million and will receive royalty payments on all sales, and
potentially up to a further $45 million in commercial and
performance driven sales milestone payments.
-- Middle East: MED3000 marketing authorisation granted in six Middle Eastern countries.
o Marketing authorisation under the Eroxon(R) brand name
recently granted in the Kingdom of Saudi Arabia, one of the top ten
ED markets in the world by value.
o Initial Middle East launch planned in Q4 2023.
Board updates
-- Jeff Needham appointed Chairman in July 2023. Jeff, has been
a member of Futura's Board since October 2021 and succeeds John
Clarke. The search for a new Non-Executive Director is at an
advanced stage.
James Barder, Chief Executive Officer, Futura Medical said: "
Futura has maintained the momentum achieved over the past three
years by delivering its first significant recurring revenues. The
Company has achieved major milestones including the successful
launches of Eroxon (R) in the UK and Belgium and most recently
online in Italy, France and Spain, received US FDA approval of
MED3000 and signed the subsequent US commercialisation agreement
with Haleon, one of the largest consumer healthcare companies in
the world. We look forward with growing confidence to the remainder
of 2023 and are now on the path towards sustained profitability by
2025.
Jeff Needham, Chair of Futura Medical commented: "The Company
has made significant progress during the first half of the year and
the Futura team is excited to be building a valuable, high-quality
brand and profitable business. As Futura enters an exciting new
chapter in its development, on behalf of the Board I would like to
thank our shareholders for their continued support. I also wish to
extend our thanks to John Clarke for his service to the Company as
Chairman over the years. He leaves the Company in a strong
position, poised for rapid growth."
Webcast
The Executive Team have hosted a pre-recorded webcast
presentation which is now available within the Investor
Centre section of the Futura company website at https://www.futuramedical.com/ .
For further information, please contact:
Futura Medical plc
James Barder, Chief Executive Officer
Angela Hildreth, Finance Director, and COO
Email: investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
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
Nick Bastin/ Jonathan Edwards/ Zoe Bolt/ Elena Bates
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 882 9621
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company
developing innovative products based on its proprietary,
transdermal DermaSys(R) technology.
MED3000, the Company's breakthrough treatment for erectile
dysfunction ("ED") has a unique evaporative mode of action and is
clinically proven as an effective topical treatment for adult men
with ED, with a key claim of "Helps you get an erection within 10
minutes". Eroxon(R) is available Over the Counter ("OTC") without a
doctor's prescription. www.eroxon.com .
MED3000 is being manufactured and commercialised under the brand
name Eroxon(R) and has been granted marketing authorisation by the
FDA in the US, CE marked in Europe, UKCA marked in the UK and is
gaining regulatory approval in a growing number of countries across
the world. Futura has commercial agreements with Haleon for the US
market and Cooper Consumer Health for Europe.
Futura is based in Guildford, Surrey, and its shares trade on
the AIM market of the London Stock Exchange. www.futuramedical.com
.
Operational Review
MED3000 - Potential to become the market leader in a new OTC
category in the global sexual health market
MED3000 is Futura's breakthrough, fast acting topical gel
formulation for the treatment of erectile dysfunction ("ED").
MED3000 has been granted marketing authorisation by the FDA in
the US, CE marked in Europe, UKCA marked in the UK and is gaining
regulatory approval in a growing number of countries across the
world. Saudi Arabia and Australia are the latest countries to
approve MED3000 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. The treatment has a unique evaporative
mode of action which stimulates nerve endings in the glans penis to
cause an erection.
The topical treatment is faster than on-demand oral tablet
phosphodiesterase-5 inhibitors ("PDE5i's" - oral treatments for the
treatment of ED such as Viagra(R), Levitra (R) and Cialis (R) and
their generic equivalents), MED3000 has significant benefits
allowing spontaneous rather than pre-planned sexual
intercourse.
The global prescription erectile dysfunction market is valued at
around $3.1 billion(1) with one in five men(2) suffering from it,
including around 22 million in the USA, and 20 million across the
UK, Germany, France, Italy and Spain(3) .
Futura's achievement of OTC status for MED3000 as a clinically
proven treatment for ED in key global regions, in particular the
USA and Europe, continues to be one of two powerful differentiating
factors given the limited availability of OTC PDE5i's around the
world, along with its rapid speed of action, helping men get an
erection within 10 minutes.
Building a global network and brand
Futura has made significant progress in establishing a network
of licensing and distribution partners with strength in brand
building, pharmaceutical credibility and regional infrastructure
and marketing expertise for long-term profitable distribution of
MED3000 across the globe.
The Company recently announced an agreement with global consumer
healthcare Company Haleon plc, to commercialise MED3000 in the USA,
the largest potential ED market OTC in the world.
This ground breaking deal adds to existing commercial agreements
in place in other key markets, including the EU, UK, Switzerland,
South Korea, Brazil, Mexico and the Middle East, and has seen the
successful launch of MED3000, under the brand name Eroxon (R) , in
both the UK and Belgium, as well as more recent online launches in
Italy, France and Spain.
The Company continues to receive significant interest from a
number of credible parties for the remaining geographic marketing
rights that are as yet unlicensed.
With further commercial agreements and product launches planned
through the remainder of 2023 and beyond, Futura is well positioned
to continue on its growth trajectory, bringing a new OTC ED
breakthrough treatment to sufferers globally.
UK and Europe - Successful Eroxon (R) launch
MED3000, under the brand name Eroxon(R), is the first
pan-European clinically proven topical treatment for ED and is
available and now on sale OTC in Belgium and the UK. With 33
million ED sufferers(3) who use 355 million treatment doses(1) per
year situated in the UK and Europe, this is a significant market
for Futura.
In March 2023, Futura's EU and UK distribution partner initiated
pre-launch activities of Eroxon (R) ahead of an online and retail
launch in the UK and Belgium, supported by marketing and
promotional advertising and more recently an initial online only
launch in Italy, France and Spain.
Upon launch in April 2023, Eroxon was exclusively available
within Boots for Pharmacy sales in the UK, where Eroxon (R) is
available in over 1,000 stores across the country. Our distributor
is now rolling Eroxon (R) out across other key retailers and we
expect Eroxon (R) to be available in over 2,500 stores across the
UK by the end of 2023. This represents a distribution reach, in the
UK, of around 70%.
Eroxon (R) sales to date have exceeded targets
Following its initial launch online across Europe in March 2023
and being made available to purchase in Belgium and in retail
pharmacies in the UK in April 2023, whilst early days, our
distributor has reported strong sales and the Futura Board believes
this underlines the unique product differentiators that Eroxon (R)
brings to clinically proven ED treatment options. As reported
during our investor seminar in late June, feedback from our
distributor noted that in its first week of sales, Eroxon (R) was
the fastest selling product on Boots.com, at a rate of "one sold
every 30 seconds" and was the most successful OTC launch Boots had
seen in a long time.
Eroxon (R) sales are on track to exceed expectations versus its
original first year forecasts, with Eroxon (R) expected to gain
around a 20% share of the clinically proven ED treatment market,
with these being largely incremental, demonstrating encouraging
signs of consumer acceptance and repeat purchase. Feedback has been
positive, with a very low level of complaints received regarding
lack of efficacy and side effects, which the Futura Board believes
illustrates a high degree of consumer satisfaction.
Over the next six months or so, our distributors will look to
move into the next phase of its rollout and launch of Eroxon (R)
with at least a further ten new country launches.
USA - World leading consumer healthcare Company, Haleon, to
commercialise MED3000
In June 2023, MED3000 was granted marketing authorisation to be
legally marketed in the USA, the biggest consumer healthcare market
globally, as the first topical gel treatment for ED available OTC.
It has been approved as an effective, clinically proven treatment
for ED along with a fast acting 10-minute claim.
Following the FDA approval, the Company announced in July that
it had entered into a ground breaking licensing agreement with
world leading consumer healthcare Company Haleon for the rights to
exclusively commercialise MED3000 in the USA. As part of the
agreement, Futura received an initial upfront payment of $4
million, will receive further royalty payments on all sales, and
potential commercial and performance driven sales milestone
payments totalling between $5 million and $45 million payable over
the course of several years.
Haleon will be responsible for all investment activities related
to the launch and marketing of the product in the USA, with Futura
providing ongoing technical support for OTC product development and
commercialisation opportunities.
With the USA being the largest potential ED market OTC in the
world and the majority of ED sufferers in the country currently not
treating their condition, MED3000 has the opportunity to meet the
needs of many of these ED sufferers by providing access to an
effective and fast-acting treatment with an excellent safety
profile that can be purchased without a prescription.
US commercial opportunity
Independent Ipsos market research from 2022, commissioned by
Futura, demonstrated dissatisfaction from ED sufferers with
PDE5i's, especially among Viagra(R) users.
The research has further shown that US men with ED spend between
$600 and $3,500 per year on the treatment of their ED (including
out of pocket cost for medication, doctor visits, refills and extra
costs for additional doses)(4) . The price difference being made up
by whether the patient is prescribed generic or more expensive
branded PDE5i's. The research also indicated that the average US
man with ED attempts intercourse around 70 times per year. Assuming
a $5-$8 cost per single dose tube, this would equate to $350-$560
per year - making MED3000 a cost effective solution.
Gulf Co-operation Council ("GCC") region and other Middle
Eastern countries - Further approvals received
Eroxon has now been granted marketing authorisation in six
Middle Eastern countries, including the key markets of Saudi Arabia
and the United Arab Emirates (UAE), with an initial launch planned
in Q4 2023. Saudi Arabia is one of the top ten ED markets in the
world by value(5) .
Our distributor will hold a launch symposium showcasing Eroxon
(R) at the 20 (th) Urological Association of Asia Congress 2023 ,
which is being held from 28 September to 1 October 2023 in
conjunction with the 12th Emirates International Urological
conference in Dubai, UAE.
China and South East Asia - Termination of commercial
agreement
In March 2021 Futura announced a Joint Collaboration with
Co-High for the regulatory development, approval and
commercialisation of MED3000 in South East Asia. Unfortunately,
this collaboration has not progressed as Futura had hoped and, as a
consequence, Futura has recently terminated the agreement with
Co-High due to their non-performance of contractual
obligations.
The region remains a significant commercial opportunity and
Futura continues to receive a growing number of enquiries,
especially following the recent FDA approval of MED3000. Futura's
corporate advisors have been progressing discussions with a number
of credible potential distributors and we look forward to updating
shareholders in due course. Nevertheless, further clinical trials
will be required, as previously disclosed, for MED3000 to gain
marketing authorisation in the key ED market of China.
Manufacturing
MED3000 supply is ISO 13485 accredited with a competitive cost
of goods. One of Futura's key objectives is ensuring a robust and
competitive supply chain through contract manufacturing
organisations ("CMO"). Futura engaged a US FDA, EMA (" European
Medicines Agency") and UK approved CMO in 2021 and scaled up
manufacturing for sufficient production capacity to meet initial
demand. Orders have already been received and fulfilled from
Futura's existing partners. A second CMO has now been added to meet
projected sales demand.
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. MED3000 patents are now
filed in all major ED markets considered necessary to protect the
commercial interests of MED3000. Patent protection will extend to
2040, once granted.
In consumer health and over-the-counter markets, an established
brand name is paramount to ensuring product price and sales volume
stability for many years. Futura is working with commercial
partners to help establish global awareness of the Eroxon(R)
trademark, consumer trust and build worldwide brand integrity.
Research and Development
Futura's priority remains to fully leverage MED3000's
significant potential in major markets throughout the world as
marketing approvals for ED treatment accumulate and regional and
country product launches take place. Futura has received feedback
from commercial partners indicating interest in expanding the
MED3000 brand with innovative product line extensions and 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. Market research
has already been undertaken to identify product extensions and
potentially new market segments for an OTC product within the
sexual health category.
Development is now progressing to expand our research and
development pipeline whilst balancing these costs against our
ambitions to become a highly profitable company. Further updates
will be provided to shareholders in due course.
Board changes
Futura benefits from the extensive knowledge and experience of
its highly skilled Board. In July 2023 Non-Executive Chairman, John
Clarke, who was instrumental in driving the Company's strategy and
success, stepped down. His departure was part of a planned
transition with Independent Non-Executive Director, Jeff Needham,
succeeding John as Chairman.
Prior to Jeff joining the Company as a Non-Executive Director of
the Company in October 2021, he had been President of Perrigo
Consumer Self-Care Americas (including USA) and Executive Vice
President at Perrigo Company plc, the US-based manufacturer and
largest marketer of generic consumer healthcare products.
A search for a new Non-Executive Director is at an advanced
stage and an announcement will be made in due course. Andrew Unitt,
as Senior Independent Director, has assumed the Chair of both the
Remuneration and the Nominations Committees, in addition to his
existing role as Chair of the Audit Committee until a new
Non-Executive Director is appointed.
Outlook
Futura has made rapid progress in achieving an expansive global
network of licensing and distribution partners for MED3000, which
now includes the USA, the largest potential ED market OTC in the
world and has now transformed itself from wholly
development-focused, into a commercially-focused organisation that
is selling its innovative lead product. There is strong interest
for the remaining countries where MED3000 has not yet been licensed
and the Company, along with its advisors, are progressing
discussions with potential interested parties.
As local marketing approvals are being granted, the focus has
switched to preparation and execution of product launches, to
growing and accelerating revenue generation, as well as ensuring
secure, competitive and scalable product supply.
Looking forward, we are proud that increasing numbers of ED
sufferers will have the chance to benefit from MED3000 as the roll
out is expanded into other geographical markets, including the USA.
The Company anticipates reaching around a break-even position in
2024, reflecting the receipt of gross profits from Eroxon (R) sales
in the Middle East, UK and EU, as well as the upfront US$4 million
milestone payment received from Haleon in July 2023, which is
expected to be recognised in 2024. The launches to date have put
the Company on the path towards profitability and the upfront
payments received ensure that the Company is well funded to deliver
on its potential.
Financial Review
Revenue
Revenue of GBP1.7 million (H1 2022: nil) was recorded during the
period and is wholly related to sales of Eroxon (R) as Futura's
European commercial partner launched Eroxon (R) in the UK and
Belgium in April 2023.
Research and Development costs
The consolidated statement of profit and loss includes
development expenditure of GBP0.8 million (H1 2022: GBP1.9 million)
and mainly relates to costs incurred generating additional data to
support the responses to questions raised by the FDA in relation to
MED3000. In addition, other research costs relating to
manufacturing were incurred as part of an assessment of
manufacturing capacity. Further capital expenditure in supply chain
is planned to be incurred in 2023 and 2024 to increase capacity to
meet demand.
Administrative costs
Costs totalling GBP2.0 million in the period (H1 2022 GBP0.9
million) include GBP0.65 million of non-cash share based payment
charges (H1 2022 GBP0.1 million) and other one-off advisory costs
relating to the conclusion of the US commercial agreement. Other
costs incurred related to the supply chain along with some
marketing costs incurred supporting our commercial partners ahead
of the launch of Eroxon (R) . In the period there was no change to
overall headcount however the increase in administrative costs and
commensurate decrease in R&D costs relate to the change in
allocation of cost of internal personnel as a result of the
commercialisation of Eroxon (R) following the launches in Europe.
Futura maintains its commitment to keep tight control of a central
cost base.
Tax
A tax credit of GBP0.2 million (H1 2022: GBP0.35 million) is
related to an estimate of R&D tax credits that can be claimed
in respect of the period. This is a reduction on the previous
period as R&D activities have reduced whilst resources have
been focused on supporting Eroxon(R) through the early stages of
commercialisation.
Loss per share
The basic loss per share for the period ending 30 June 2023 was
0.61p (H1 2022: 0.87p). Details of the loss per share calculations
are provided in Note 5.
Balance Sheet
Net assets at 30 June 2023 were GBP8 million (H1 2022: GBP7.3
million), including cash of GBP7.8 million H1 2022: GBP6.68
million). This followed the receipt of GBP4.37 million of funds
received from an institutional investor upon exercise of 10,375,500
warrants at a price of GBP0.40 per ordinary share.
Going concern
The Directors have prepared the financial statements on a going
concern basis. Further information is described in Note 3.
Post period events
In July 2023, Futura entered into a commercial licencing
agreement with Haleon in respect of Eroxon. Upon execution of this
agreement, Futura received $4 million (GBP3.2 million) in the form
of an upfront milestone payment which is to be recognised as a
Contract Liability until satisfaction of the performance
obligations. The key performance obligation, which is expected to
be met in 2024, will materially cause all of the GBP3.2 million to
be recognised as revenue at that point in time on the Consolidated
Statement of Comprehensive Income.
Notes
(1) (.) Manufacturers' Selling Prices 2020: Data available for
75 countries IQVIA IMS Health
2 EMA, Withdrawal assessment report for Viagra, 2008
(3) 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.
(4) Ipsos research commissioned by Futura, 2022
(5) National Library of Medicine
Angela Hildreth
Finance Director and Chief Operating Officer
Interim Results - click below to view Futura Medical's Interim
Results
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END
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