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REG - Futura Medical PLC - Futura Medical - Interim Results 2024

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RNS Number : 4918D  Futura Medical PLC  10 September 2024

10 September 2024

Futura Medical plc

("Futura" or the "Company")

Unaudited interim results for the six months ended 30 June 2024

Maiden profit and US launch delivered ahead of market expectations

 

Futura Medical plc (AIM: FUM), the consumer healthcare company behind
Eroxon(®), that specialises in the development and global commercialisation
of innovative and clinically proven sexual health products, is pleased to
announce its unaudited interim results for the six months ended 30 June 2024
("H1 2024").

 

Financial Highlights
 ·             Revenue growth of over 300% to £7.0 million (H1 2023: £1.7million)
               o                                        generated from £3.8 million of product sales (H1 2023: £1.7 million) and
                                                        £3.2 million following the recognition of US commercial milestone received in
                                                        2023
 ·             Maiden profit after tax of £1.0 million (H1 2023: Operating loss of £2.0
               million)
               o                                        excluding the non-cash expense share-based payments charge, profit after tax
                                                        is £2.3 million
 ·             Strong cash position at 30 June 2024 of £3.9 million (HY2023: £7.8 million)
               which management anticipates will be strengthened further by a milestone
               payment due from Haleon on US launch in October 2024
 ·             The Board is confident in the outlook for the remainder of the year and
               confirms that both revenue and profit will significantly exceed market
               expectations* for the full year

Operational Highlights

 ·             Successful launches in over ten countries including key European markets such
               as France, Italy and Spain, with further launches expected in the second half
               of 2024 in both Europe and Rest of World
 ·             Two new contract manufacturers in place to strengthen supply chain and boost
               capacity
 ·             Extension of licencing agreement with Cooper to 2029
 ·             Independent consumer studies validate the strength of Eroxon(®) and provide
               valuable consumer insight

 

Post-period end

 ·             Haleon confirms pan-US launch under the Eroxon(®) brand with Eroxon(®)
               already available for pre-order online for delivery in October and
               availability in stores in the US from October. This triggers the next
               milestone payment, which is of a similar scale to the previous one
 ·             M8 Pharmaceuticals, Inc ("M8") confirms first Latin American country launch in
               Mexico under the Eroxon(®) brand

 

*Note: The Company believes that, prior to this announcement, market
expectations for 2024 performance in terms of revenue and loss after tax were
£9.50 million and £2.63 million respectively.

James Barder, Chief Executive Officer, commented:

"It is a significant milestone to be able to announce our first profit, a year
after the initial pilot launch of Eroxon(®), and well ahead of market
expectations. We believe that this is just the beginning for Eroxon(®), our
highly differentiated treatment for erectile dysfunction which helps users get
an erection within ten minutes, as we look to build a new product and new
category within the underserved sexual health market.

"In the past year, Futura has transitioned from a loss-making R&D business
to a profitable consumer healthcare company. This is a tremendously proud
moment for me and the entire Futura team.

"We look forward with excitement to the second half of 2024 with further
launches already underway for Eroxon(®) and in particular the launch in the
US, the largest consumer healthcare market in the world, by our distribution
partner Haleon."

 

Investor Presentation

The Company will be hosting a webinar for retail investors via the Investor
Meet Company platform on 10 September 2024, at 9:00am BST. Investors can
register for the presentation via the following
link: https://www.investormeetcompany.com/futura-medical-plc/register-investor
(https://www.investormeetcompany.com/futura-medical-plc/register-investor)

 

Contacts:

 Futura Medical plc             James Barder                                              investor.relations@futuramedical.com

                                                         (mailto:Investor.relations@futuramedical.com)
                                Chief Executive Officer

                                                         +44 (0)1483 685 670
                                Angela Hildreth

                                                         www.futuramedical.com (http://www.futuramedical.com/)
                                Finance Director and COO

 Panmure Liberum                Emma Earl, Will Goode,  Mark Rogers (Corporate Finance)   +44 (0)20 3100 2000

 Nominated Adviser              Rupert Dearden (Corporate Broking)

 and Broker

 Stifel                         Alan Selby                                                +44 (0)207 710 7600

 Joint Broker                   Ben Maddison

                                Ben Good

 Alma Strategic Communications  Rebecca Sanders-Hewett                                    +44 (0)20 3405 0205

                                Sam Modlin                                                futura@almastrategic.com

                                Will Ellis Hancock

 

Notes to Editors:

Futura Medical plc (AIM: FUM) is the developer of innovative sexual health
products, including lead product Eroxon(®). Our core strength lies in our
research, development and commercialisation of topically delivered gel
formulations in sexual health products.

Eroxon(®), Futura's clinically proven lead product, has been developed for
the treatment of Erectile Dysfunction ("ED"). The highly differentiated
product, which is the only topical gel treatment for ED available over the
counter and helps men get an erection in ten minutes, addresses significant
unmet needs in the ED market.

ED impacts around 20% of men globally across all adult age brackets, with
approximately 50% of all men over 40 experiencing ED and around 25% of all new
diagnoses being in men under 40.

Futura has distribution partners in place in a number of major consumer
markets including Haleon in the US, the largest consumer healthcare market in
the world, and Cooper Consumer Health in Europe. Eroxon(®) has been nominated
for a number of healthcare industry awards and has won several to-date.

 

Forward-looking statements

 

This document contains certain projections and other forward-looking
statements with respect to the financial condition, results of operations,
businesses, and prospects of Futura. The use of terms such as "may", "will",
"should", "expect", "anticipate", "project", "estimate", "intend", "continue",
"target" or "believe" and similar expressions (or the negatives thereof) are
generally intended to identify forward-looking statements. These statements
are based on current expectations and involve risk and uncertainty because
they relate to events and depend upon circumstances that may or may not occur
in the future. There are a number of factors that could cause actual results
or developments to differ materially from those expressed or implied by these
forward-looking statements. Any of the assumptions underlying these
forward-looking statements could prove inaccurate or incorrect and therefore
any results contemplated in the forward-looking statements may not actually be
achieved. Nothing contained in this document should be construed as a profit
forecast or profit estimate. Investors or other recipients are cautioned not
to place undue reliance on any forward-looking statements contained herein.
Futura undertakes no obligation to update or revise (publicly or otherwise)
any forward-looking statement, whether as a result of new information, future
events or other circumstances.

 

 

 

Chief Executive's Review

 

A period of continued progress

The first half of 2024 has seen us build upon the progress achieved in 2023,
in which we delivered our first meaningful revenues from our lead product
Eroxon(®). I am delighted to be reporting on a period that has seen us
declare our maiden profit, a significant milestone for both the Company and
its shareholders, whilst delivering further revenue growth.

Eroxon(®) initially launched in early Q2 2023 in two markets and is now on
sale in more than ten countries, including many key EU markets. To be able to
walk into leading Pharmacy and Health retailers across Europe, see our product
on the shelves, and be able to purchase it without the need for a
prescription, is testament to the progress we have made. Each launch has
provided insightful learnings to our distribution partners which we are able
to build upon and continue to execute against our key priorities and help
improve future launches and rollouts in what is an exciting new category in
most countries.

Post-period end, we were pleased to announce that Haleon had confirmed that it
expected Eroxon(®) to be available in the US before the end of this year. As
announced in late August, as of 1 September 2024, Eroxon(®) is available for
pre-order online for delivery in October and will also be available in stores
at the same time, a major milestone on our journey to addressing the growing
needs within the over-the-counter ("OTC") sexual health market. The US launch
in turn triggers the next milestone payment which the Company will receive
from Haleon.

Delivering further revenue growth and maiden period of profit

In the period, not only did revenue grow by over 300% but importantly, we
delivered our maiden profit. Revenue was made up of significantly increased
product sales ,as the European roll-out continued and key territories were
launched in the period, as well as recognition of the US commercial milestone
received in 2023. Our cash position is robust and will enable us to execute on
the global commercialisation of Eroxon(®).

Eroxon(®), a disruptive product

Erectile dysfunction ("ED") should not be underestimated. Globally it impacts
approximately 20% of men(1), affecting all age ranges, with approximately 50%
of men over 40 experiencing ED(2) and around 25% of new diagnoses being in men
under 40(3). Moreover, with a globally ageing population, this is a large
market that is expected to continue to grow. Research shows this is an
under-served market with the majority of those affected yet to be diagnosed,
whilst within the cohort that have been diagnosed, there is a high proportion
that are not on treatment or stop treatment after one year. Our market
research shows slow onset of action, side effects, ease of access and costs as
the main sources of their dissatisfaction with current treatment options(4).

Our lead product, Eroxon(®), addresses many of these needs. Clinically
proven, it is the only topical gel treatment for ED available OTC and helps
men get an erection in ten minutes. As a "drug-free" treatment it is absent of
the many side-effects associated with alternative therapies. Cost and
embarrassment can be a blocker to seeking a solution to ED, particularly in
many parts of the world where ED still holds a significant stigma within
society. Eroxon(®), is a clinically proven treatment available without the
need of consulting with a doctor or healthcare practitioner ("HCP"), reducing
the need for consultation fees and significantly improving ease of access for
men and their partners.

The treatment of ED in the form of Eroxon(®) is a new OTC category in most
countries where current first line treatment options are predominantly PDE5i's
which require a prescription. As expected and as with any major new OTC
category, whilst this represents a major business opportunity there are normal
challenges in building brand awareness and educating consumers in the best use
of the product without the direction of an HCP. Also, social, cultural and
buying habits are different from one country to the next which will all
influence sales uptake with patterns varying by country, something not always
easy to predict. Nevertheless, we are very pleased with the overall
performance of the launches of Eroxon(®) so far with the product being well
received and key learnings being assimilated as we roll out into new
geographies to ensure a sustainable and profitable business going forwards.

To identify key learnings, our distribution partners, who pay for and are
responsible for all advertising and promotional spend, have independently
conducted four "home-user" studies with over 600 users to validate the
strength of the proposition. This has confirmed results that are aligned with
the Eroxon(®) clinical efficacy data (>60% success rate) and provided real
world evidence to further refine the marketing positioning. This is to augment
the early repurchase information from the UK which is notoriously difficult to
estimate with men and their partners able to purchase the treatment as well as
over 5,000 different retail outlets (which don't necessarily track individual
purchases) but we believe to be in the region of 15% to 20%. The UK is also
the only major country where PDE5i's; Viagra Connect and Cialis Together are
classified as OTC presenting a highly competitive market which may impact the
repurchase rate. This contrasts with the United States and the majority of EU
member countries where no PDE5i products are available OTC.

Latest market research has highlighted some interesting learnings to augment
consumer education and product positioning:

 ·             Futura's clinical studies showed that Eroxon(®) used as part of foreplay
               improved satisfaction / efficacy by around 30% yet only one in two men are
               using Eroxon(®) as part of foreplay
 ·             Satisfaction levels are higher in men less than 60 years old and especially in
               the 30 to 45 age group
 ·             Satisfaction levels are also higher between couples rather than in single men
               using Eroxon(®) on a date or solo use
 ·             With PDE5i treatments, men are used to trying to pre-empt when they are going
               to have sex and consequently, we are seeing one in five of men unnecessarily
               adopting the same approach with Eroxon(®), rather than using the treatment
               spontaneously or indulging in foreplay
 ·             Men frequently seek prescriptions for the maximum PDE5i dosage and then cut
               the tablet in two to optimise value. Again, we are seeing some men adopting
               the same economic approach with Eroxon(®) and not using the entire contents
               of the single dose Eroxon(®) tube
 ·             Side effect profile remains extremely low with a reported incidence rate of
               less than one in 14,000 packs with all side effects that have been reported
               are non-serious.

It is important that these learnings are absorbed and acted upon, making each
launch and the continuous marketing campaigns, utilising both social media and
traditional marketing methods more effectively as our distribution partners
continue to build awareness and brand value.

In the category where there has been little innovation in two decades,
education is needed for consumers and HCPs, and we expect to gain further
knowledge from additional launches that will then enable us and our partners
to continuously refine our approach as we progress with further market
expansion across the globe.

Continued progress against our key priorities

2023 saw us move from a pre-revenue R&D company to a business with first
meaningful revenues being generated from commercial sales of Eroxon(®). This
was a significant step forward and therefore, as announced at our last set of
results, it felt appropriate to refine our strategy as follows:

To commercialise innovative and clinically proven products for the OTC sexual
health market. We will partner with leading consumer healthcare partners who
are well resourced to commit significant marketing spend and expertise to
engage effectively with consumers.

This approach is aligned with the demographic changes of ageing populations,
increasing prosperity and the expectation of people to lead a full and active
life no matter their age.

With our proven innovative R&D team, we will look to fulfil the needs of
the large, underserved OTC sexual health market.

As previously disclosed, we are now reporting against three strategic pillars:

 1.      Address the growing needs within the OTC sexual health market
 2.      Broaden the Company's clinically proven product range leveraging its
         innovative and experienced R&D capability whilst being mindful of costs
         and focusing on ROI.
 3.      Commit to delivering strong returns for shareholders, sustained profitability
         and financial discipline

In our 2023 Annual Report we set out three priorities for the year ahead, and
I am delighted to say that we have made good progress in line with these so
far, with more to come in the second half of the financial year.

 

As a reminder, our priorities for 2024 were:

 ·             Address - Address worldwide demand for Eroxon(®) through strengthening our
               supply chain and commercial network whilst achieving further regulatory
               approvals and further launches across the world
 ·             Broaden - Explore other range extensions as well as new innovative products
               within the sexual health category to meet further unmet demand, supported by
               clinical data whilst remaining mindful of costs
 ·             Commit - Deliver further revenue growth and progress on the path towards
               profitability in the next 12 months

Address:

In April, we stated that we expected to have commenced full launches in at
least ten countries including key European markets such as France, Italy and
Spain during the first half of 2024, and I am pleased to confirm that these
launches have successfully taken place alongside our partner Cooper Consumer
Health.

In what is a major milestone for Futura, Haleon has confirmed that Eroxon(®)
is now available to pre-order online and will be available throughout all
major US retailers next month. As is the case with all our distribution
partners Haleon will both fund and be responsible for all advertising and
promotional activities related to the launch and marketing of the product in
the US. We believe Haleon, with its strong capabilities in brand-building and
marketing through an unrivalled breadth of channels, as well as its
connections and market reach, makes the ideal partner to introduce Eroxon(®)
to the millions of men with ED in the US.

We are working closely with our distribution partner for the Middle East,
Labatec Pharma, who has launched in two markets. Nevertheless, they face some
challenges to the acceptance of Eroxon(®) predominantly due to the existing
widespread availability of highest dose PDE5i's within the region as well as
the cultural approach to their use.

Our distribution partner for Central and Latin America, M8, in the past month
commenced a digital launch in Mexico which will be followed up shortly with an
in store roll out across the country.

In Korea, the regulators the Ministry of Food and Drug Safety ("MFDS") were
looking to classify Eroxon(®) as a drug which would have likely entailed
additional clinical studies. This was not considered a priority for us at the
moment considering the cost of any additional clinical study in relation to
the size of the opportunity South Korea represents. We have therefore decided
not to progress in this market for the time being and by mutual agreement have
agreed with Menarini to terminate our single country agreement

Discussions are progressing well in several other key Asian markets with
potential commercial partners. Mindful of the regulatory stance adopted by the
MFDS we are clarifying the regulatory pathway in the applicable countries
before we finalise terms and will update shareholders in due course.

To ensure that we have a robust supply chain in place, which is able to
provide greater supply certainty, as well as additional capacity based on both
Futura and distribution partners' sales projections, we have commenced working
with two new contract manufacturers ("CMO"), one located in the US and the
other in the EU to supply product to our commercial partners. These supply
chain partners will be central to the long-term success of the product, and we
are working closely with them to deliver continuity of supply, with a product
of high quality at the lowest cost possible. Production previously supplied
from a UK CMO has now ceased.

We continue to progress both our patent grants and trademark registrations
("IP") across the world's key markets. The initial interest and success of the
Eroxon(®) launches is perhaps reflected in the fact that to-date the company
retained by Futura to protect our IP interests has so far taken down over
1,200 sites that have been selling product that has been infringing our
rights. We will not only continue to develop new IP of value for shareholders
but will aggressively protect what we have already established.

Broaden

We believe that having follow-on brand extensions and new products within the
OTC sexual health category is vital to demonstration both innovation and
provide long-term growth. As such, we are exploring other range extensions as
well as new innovative products within the sexual health category to meet
further unmet demand, supported by clinical data whilst remaining mindful of
costs. Proof of concept work is underway and assuming this progresses well we
expect to provide shareholders more information by the end of 2024.

Commit

We are proud to have announced our maiden profit a year after delivering our
first revenues and we will continue to drive growth as well as R&D
innovation. In this early stage of launches, whilst we expect growth, it will
not be a matter of simply multiplying the prior periods together and will vary
period on period. This is due to new launches, the recognition of milestone
payments, channel fill, different revenue models with our partners as well as
different cultural and regulatory challenges from one country to the next. We
are committed to driving significant growth and have an exceptionally
important period ahead which will provide us with a platform for further
growth and profits in the years ahead.

Looking ahead with confidence

H1 2024 has been another progressive period for Futura, delivering significant
revenue growth and our first period of profitability. We have also continued
to execute in line with our strategy and we are well on our way to
successfully commercialising Eroxon(®) across the globe.

Over the next six weeks we will deliver on a key milestone in the Company's
history, launching in the US, and we are extremely excited to see the reaction
in the market to Eroxon(®). We will update shareholders in due course on the
first phase of the US launch.

With first mover advantage already showing its benefit, alongside the size of
the target market and the continuous progress we are making, we look forward
to the year ahead with growing confidence.

James Barder

Chief Executive Officer

 

Sources:

1.  EMA, Withdrawal assessment report for Viagra, 2008

2.  Feldman HA et al. J Urol 1994; 151: 54 - 61

3.  Pozzi, J of Sexual Medicine, Volume 20, 2022,

4.  Ipsos research carried out on behalf of Futura in the US, 2022

 

Financial Review

Futura has transitioned from a pre-revenue R&D company to a consumer
healthcare product company with significant commercial sales. It is extremely
pleasing therefore to report that we are now profitable, cash generative and
we have sufficient cash on our balance sheet to allow us to continue the
global commercialisation of Eroxon(®).

In the first half of 2024 we made important decisions to invest in protecting
our supply chain to ensure flexibility and continuity of supply. This
investment will continue into mid-2025 and whilst this has resulted in a
slight decrease in margin in H1 2024 and some additional exceptional General
& Administrative costs which will continue into 2025, we believe this was
an important step, at the right time in our journey, to ensure we are
protected and well invested to handle the capacity needs in the period ahead.

Revenue

Total revenues reported of £7.0 million (H1 2023: £1.7 million) representing
an increase of over 300%. Revenue was generated from product sales of £3.8
million (H1 2023: £1.7 million) and recognition of a commercial milestone
payment received in 2023 of £3.2m (H1 2023: nil)

Reported product sales of Eroxon(®) for the half year were up 130% to £3.8
million (H1 2023: £1.7 million) as the European roll-out continued and key
territories were launched in the period including France, Italy, Spain and
Portugal. Product revenues in newly launched territories always include an
element of channel fill so are not always an accurate representation of
product sales in the initial stocking period.  As our commercial distributors
continue to roll out launches across further countries, it will remain
challenging to predict exact timing of revenues and royalties especially given
non-linear nature of channel fill and launch timelines. Neverthless, we expect
further launches in the second half of 2024 and will provide updates as
appropriate.

In July 2023, the group signed an exclusive commercial agreement with Haleon
to commercialise Eroxon(®) in the USA and an upfront payment of £3.2 million
(US$4.0 million) was received in 2023 upon execution of the agreement. As
previously disclosed, the payment was recognised in the current period.
Further milestone payments are expected as this relationship progresses,
alongside royalty payments on all sales by Haleon.

Post-period end Haleon confirmed the pan US launch under the Eroxon(®) brand
would be going live in October 2024, with online pre-ordering already
available. This triggers the next milestone payment, which is of a similar
scale to the previous milestone payment, and is recognisable upon receipt in
2024.

Cost of Sales

Cost of sales rose by 175% to £2.2 million (H1 2023: £0.8 million)
reflecting the rise in sales volumes.  Gross profit on Eroxon(®) sales
increased by 90% to £1.7 million (H1 2023: £0.9 million) Gross profit
margins on Eroxon(®) sales reduced to 44% (H1 2023: 54%) reflecting, as
previously disclosed, an increase in manufacturing costs in order ensure we
meet increased capacity requirements, which is expected to normalise in 2025.

Operational costs

Total operational costs were £4.0 million (H1 2023: £2.9 million) and
comprised of research and development costs of £0.6 million (H1 2023: £0.8
million) and operating expenses of £3.4 million (H1 2023: £2.1 million)
which included non-cash share-based payments charge of £1.3 million (H1 2023:
£0.7 million) with the remaining rise in costs predominantly relating to the
short-term investment into supply chain,  investment required to increase
manufacturing capacity and ensure continuity of supply. Other core operating
costs remain relatively static.

Research and development costs

Research and Development ("R&D") costs for the period were in line with
those at the 2023 year-end (£2.1 million) reflecting the focus shifting
towards commercialisation of Eroxon(®) as headcount costs are now allocated
to administrative expenses. In the second half of the financial year these are
expected to increase slightly as we commence some proof-of-concept projects on
new products.

Profit after tax

Total profit after tax for the period was £1.0 million (H1 2023: loss after
tax £1.8 million). Excluding non-cash share-based payments, profit after tax
would be £2.3 million (H1 2023: loss after tax £1.1 million)

Cash

The cash balance as at 30 June 2024 was £3.9 million (H1 2023: £7.8 million)
reflecting normal working capital requirements, the investment into
manufacturing and the US commercial milestone which was received in 2023 but
recognised in H1 2024.

Overall, management remain confident to exceed expectations for the full year
to 31 December 2024.

Going concern

The Directors have prepared the financial statements on a going concern basis.

 

The information communicated in this announcement contains inside information
for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014
as amended by the Market Abuse (Amendment) (EU Exit) Regulations 2019.

 

 

Consolidated Statement of Comprehensive Income

For the six months ended 30 June 2024

 

                                                                                        Unaudited                              Unaudited                              Audited

                                                                                        6 months ended                         6 months ended                          year

                                                                                        30 June                                30 June                                 ended

                                                                                                    2024                                2023                          31 December

                                                                                                                                                                                   2023

                                                                                 Notes                    £                                      £                                      £
 Revenue                                                                                7,000,693                              1,703,447                                     3,100,968
 Cost of Goods                                                                          (2,180,023)                            (794,386)                              (1,326,743)
 Gross profit                                                                           4,820,670                              909,061                                1,774,225
 Research and development costs                                                            (609,294)                              (819,474)                           (2,045,988)
 Administrative costs                                                                     (3,391,674)                            (2,048,659)                          (6,692,007)
 Operating profit/(loss)                                                                819,702                                (1,959,072)                            (6,963,770)
 Finance income                                                                                   46,939                                 -                                      71,797
 Profit/(loss) before tax                                                               866,641                                (1,959,072)                            (6,891,973)
 Taxation                                                                        10     135,000                                 200,000                               379,074
 Total comprehensive profit/(loss) for the period attributable to owners of the                 1,001,641                              (1,759,072)
 parent company

                                                                                                                                                                      (6,512,899)

 Basic profit/(loss) per share (pence)                                           5      0.33                                   (0.61)                                 (2.21)
 Diluted profit/(loss) per share (pence)                                         5      0.32                                   (0.61)                                 (2.21)

 

Consolidated Statement of Financial Position

As at 30 June 2024

 

 

                                                   Unaudited                      Unaudited                 Audited

                                                 30 June                        30 June                     31 December

                                                       2024                           2023                           2023
                                       Notes                £                              £                              £
 Assets
 Non-current assets
 Plant and equipment                          3,248,057                      1,099,640                      2,484,748
 Total non-current assets                     3,248,057                      1,099,640                      2,484,748

 Current assets
 Inventories                                  140                            809                            339
 Trade and other receivables           6      1,795,635                      1,070,366                      1,240,174
 Current tax asset                            501,910                        197,836                        376,910
 Cash and cash equivalents             7      3,920,326                      7,838,889                      7,714,182
 Total current assets                                 6,218,011                      9,107,900              9,331,605

 Liabilities
 Current liabilities
 Trade and other payables              8      (1,657,291)                    (2,195,326)                    (6,339,534)
 Total liabilities                            (1,657,291)                    (2,195,326)                              (6,339,534)
 Total net assets                             7,808,777                      8,012,214                      5,476,819

 Capital and reserves attributable to

 owners of the Parent Company
 Share capital                         11     603,727                        598,143                        602,812
 Share premium                                       71,091,260                     70,930,527              71,068,945
 Merger reserve                                        1,152,165                      1,152,165             1,152,165
 Retained losses                              (65,038,375)                   (64,668,621)                   (67,347,103)
 Total equity                                           7,808,777                      8,012,214            5,476,819

Consolidated Statement of Changes in Equity

For the six months ended 30 June 2024

 

                                                                    Share     Share             Merger     Other       Retained      Total

                                                                    Capital   Premium           Reserve     Reserve    Losses        Equity
                                                              Note  £         £                 £          £           £             £
 At 1 January 2023 - audited                                        576,093   66,545,796        1,152,165  165,868     (63,720,369)  4,719,553
 Total comprehensive loss for the period                            -         -                 -          -           (1,759,072)   (1,759,072)
 Share-based payment                                                -         -                 -          -           644,952       644,952
 Shares issued during the period                                    175       31,606            -          -           -             31,781
 Convertible loan notes and warrants conversion and exercise  12    21,875    4,353,125         -          (165,868)   165,868       4,375,000
 Transactions with owners                                           22,050    4,384,731         -          (165,868)   810,820       5,051,733
 At 30 June 2023 - unaudited                                        598,143   70,930,527        1,152,165  -           (64,668,621)  8,012,214
 Total comprehensive loss for the period                            -         -                 -          -           (4,753,827)   (4,753,827)
 Share-based payment                                                -         -                 -          -           2,075,345     2,075,345
 Shares issued during the period                                    4,669     138,418           -          -           -             143,087
 Transactions with owners                                           4,669     138,418           -          -           2,075,345     2,218,432
 At 31 December 2023 - audited                                      602,812   71,068,945        1,152,165  -           (67,347,103)  5,476,819
 Total comprehensive loss for the period                            -         -                 -          -           1,001,641     1,001,641
 Share-based payment                                                -         -                 -          -           1,307,087     1,307,087
 Shares issued during the period                                    915       22,315            -          -           -             23,230
 Transactions with owners                                           915       22,315            -          -           1,307,087     1,330,317
 At 30 June 2024 - unaudited                                        603,727   71,091,260        1,152,165  -           (65,038,375)  7,808,777

Consolidated Statement of Cash Flows

For the six months ended 30 June 2024

 

                                                                                Unaudited                                     Unaudited                      Audited

                                                                                6 months                                    6 months                        year

                                                                                     ended                                          ended                    ended

                                                                                   30 June                                    30 June                          31 December

                                                                                          2024                                        2023                                2023
                                                                                               £                                        £                   £
 Cash flows from operating activities
 Profit/(loss) before tax                                                  866,641                                    (1,959,072)                           (6,891,973)
 Adjustments for:
 Depreciation                                                              59,411                                     65,282                                              130,272
 Loss on disposal of fixed assets                                          513                                        -                                     48,865
 Finance Income                                                            (46,939)                                   -                                     (71,797)
 Share-based payment charge                                                1,307,087                                  644,952                               2,720,297
 Cash flows generated by/(used in) operating activities before changes in
 working capital

                                                                              2,186,713                                  (1,248,838)                         (4,064,336)

 Decrease / (increase) in inventories                                      200                                        (809)                                 (339)
 Increase trade and other receivables                                             (555,461)                                  (804,682)                           (974,490)
 (Decrease) / increase in trade and other payables                              (4,682,240)                                442,217                          4,586,424
 Cash used in operations                                                   (3,050,788)                                (1,612,112)                           (452,741)

 Income tax received                                                       -                                          1,024,994                             1,022,994
 Net cash generated by/(used in) operating activities                      (3,050,788)                                (587,118)                                    570,253

 Cash flows from investing activities
 Purchase of plant and equipment                                                   (823,233)                                  (6,886)                                (1,505,849)
 Interest received                                                         46,939                                     -                                                  71,797
 Cash used in investing activities                                         (776,294)                                  (6,886)                                         (1,434,052)

 Cash flows from financing activities
 Issue of ordinary shares                                                  23,230                                     4,406,781                                       174,868
 Exercise of warrants                                                      -                                          -                                     4,375,000
 Cash generated by financing activities                                    23,230                                     4,406,781                             4,549,868

 (Decrease)/ Increase in cash and cash equivalents                         (3,803,852)                                3,812,777                             3,686,069
 Cash and cash equivalents at beginning of period                              7,714,182                                  4,026,112                            4,026,112
 Net foreign exchange differences                                          9,996                                      -                                     2,001
 Cash and cash equivalents at end of period                                3,920,326                                  7,838,889                             7,714,182

 

 

Notes to the Consolidated Interim Financial Statements

For the six months ended 30 June 2024

 

1.   Corporate information

 

The interim condensed consolidated financial statements of Futura Medical plc
and its subsidiaries (the "Group") for the six months ended 30 June 2024 were
authorised for issue in accordance with a resolution of the Directors on 9
September 2024. Futura Medical plc (the "Company") is a public limited company
incorporated and domiciled in the United Kingdom and whose shares are publicly
traded on the AIM Market of the London Stock Exchange. The registered office
is located at Surrey Technology Centre, 40 Occam Road, Guildford, Surrey, GU2
7YG.

The Group is principally engaged in the development and sale of pharmaceutical
and healthcare products.

 

2.   Accounting policies

 

The accounting policies applied in these interim financial statements are
consistent with those of the annual financial statements for the year end 31
December 2023, as described in those financial statements except for the new
accounting policies described below.

These condensed interim consolidated financial statements for the six months
ended 30 June 2024 and for the six months ended 30 June 2023 do not constitute
statutory accounts within the meaning of section 434(3) of the Companies Act
2006 and are unaudited.

The Group's financial information for the year ended 31 December 2023 has been
extracted from the financial statements of the statutory accounts ("Annual
Report") of Futura Medical plc, which were prepared by the Directors in
accordance with UK-adopted International accounting standards ("IFRS") in
conformity with the requirements of the Companies Act 2006 that were
applicable for the year ended 31 December 2023 and does not constitute the
full statutory accounts for that period. The Annual Report for 2023 has been
filed with the Registrar of Companies. The Independent Auditor's Report on
those financial statements was unqualified and did not contain a statement
under Section 498 (2) or (3) of the Companies Act 2006; though it did include
a reference to a matter to which the Independent Auditor drew attention by way
of emphasis without qualifying their report in relation to going concern. It
does not comply with IAS 34 Interim financial reporting, as is permissible
under the rules of AIM.

 

3.   Estimates and judgements

 

The preparation of the interim condensed consolidated financial statements in
conformity with IFRS requires management to make certain estimates,
assumptions and judgements that affect the application of accounting policies
and the reported amounts of assets and liabilities and the reported amounts of
income and expenses in the period.

 

Critical accounting estimates, assumptions and judgements are continually
evaluated by the Directors based on available information and experience. As
the use of estimates is inherent in financial reporting actual results could
differ from these estimates.

Going concern

The Group has reported a profit after tax for the six months ended 30 June
2024 of £1.00 million (six months ended 30 June 2023: loss of £1.76 million,
year ended 31 December 2023: loss of £6.51 million). The Group holds cash
balances of £3.92 million at 30 June 2024 (30 June 2023: £7.84 million, 31
December 2023: £7.71 million).

The Directors have considered the applicability of the going concern basis in
the preparation of the financial statements. This includes the review of
internal budget, financial results and cashflow forecasts for the 12 months'
period following the date of signing the financial statements. These forecasts
show that the Group has sufficient funds to allow the business to continue in
operations for at least 12 months from the date of approval of these financial
statements.

Based on the above factors the Directors believe that it remains appropriate
to prepare the financial statements on a going concern basis. The financial
statements do not include any adjustments that would result from the basis of
preparation being inappropriate.

 

Share-based payments

The Group operates an equity-settled share-based compensation plan for
employee (and consultant) services to be received and the corresponding
increases in equity are measured by reference to the fair value of the equity
instruments as at the date of grant. The fair value determination is based on
the principles of the Black-Scholes model, the inputs of which uses an input
of volatility based on historical data. Historical volatility may not be
indicative of future volatility, yet the Directors judge this to be the most
appropriate method of calculation. Given the share option expense of £1.31
million for the six months ended 30 June 2024 (six months ended 30 June 2023:
£0.64 million, year ended 31 December 2023: £2.72 million), the volatility
method used is not expected to have a material impact on these financial
statements.  Details of the fair value calculation for options granted during
the period, including other inputs into the Black-Scholes model, are disclosed
in Note 13.

 

R&D tax credits

The current tax receivable represents an estimate of the anticipated R&D
tax credit in respect of claims not yet submitted for the 2024 financial year.
The final receivable is subject to the correct application of complex R&D
rules and HMRC approval. Historically, claims have been successful, and the
Group expects the current year to be successful too.

 

4.   Segment reporting

 

The Group is focussed on the development and commercialisation of Eroxon® and
therefore operates as one segment.  The Group derives revenue from the
transfer of goods and services over time and at a point in time in the
following geographical split:

 

                  Unaudited                        Unaudited                      Audited

                   30 June                          30 June                       31 December

                  2024                             2023                             2023
                        £                                £                               £

 EU and UK       2,759,209                        1,703,447                        2,725,475
 Rest of world   1,014,830                        -                                375,493
 USA             3,226,654                        -                                -
          7,000,693                        1,703,447                        3,100,968
                                                                           Unaudited                      Audited

                                         Unaudited                          30 June                       31 December

                        30 June                                2023                             2023

                              2024
                                    £                                £                               £

 Revenue recognised at a point in time  7,000,693                        1,703,447                        3,044,075
 Revenue recognised over time           -                                -                                56,893
                     7,000,693                        1,703,447                        3,100,968

                                                                           Unaudited                      Audited

                                         Unaudited                          30 June                       31 December

                                           30 June                                2023                             2023

                                                 2024
                                                       £                                £                               £

 Revenue recognised at a point in time  7,000,693                        1,703,447                        3,044,075
 Revenue recognised over time           -                                -                                56,893
                                        7,000,693                        1,703,447                        3,100,968

5.      Profit/Loss per share (pence)

The Group reports basic and diluted earnings per common share. Basic earnings
per share is calculated by dividing the profit attributable to common
shareholders of the Company by the weighted average number of common shares
outstanding during the period.

Diluted earnings per share is determined by adjusting the profit attributable
to common shareholders by the weighted average number of common shares
outstanding, taking into account the effects of all potential dilutive common
shares, including share options and the issue of shares under the long-term
incentive share option scheme to the extent that they are deemed to be issued
for no consideration in accordance with IAS 33.

Where a loss is attributable to equity holders of the Company, the calculation
of the fully diluted loss per share is identical to that used for calculating
the basic loss per share. The exercise of share options, or the issue of
shares under the long-term incentive share options scheme, would have the
effect of reducing the loss per share and is therefore anti-dilutive under the
terms of IAS 33 'Earnings per Share'.

                                                                         Unaudited                        Unaudited                      Audited

                                                                          30 June                          30 June                       31 December

                                                                                2024                             2023                             2023
                                                                                      £                                £                               £

 Total comprehensive income attributable to the owners of the company          1,001,641                        (1,759,072)              (6,512,899)
 Weighted average number of shares                                     301,503,380                      288,974,155                      294,912,404
 Basic profit/(loss) per share (pence)                                 0.33                             (0.61)                           (2.21)

 Total comprehensive income attributable to the owners of the company          1,001,641                        (1,759,072)              (6,512,899)
 Weighted average number of shares                                     301,503,380                      288,974,155                      294,912,404
 Dilutive effect of share options                                      15,933,376                       -                                -
 Weighted average number of diluted shares                             317,436,756                      288,974,155                      294,912,404
 Diluted profit/(loss) per share (pence)                               0.32                             (0.61)                           (2.21)

 

 

6.       Trade and other receivables

                                        Unaudited                        Unaudited                      Audited

                                         30 June                          30 June                       31 December

                                               2024                             2023                             2023
                                                     £                                £                               £
 Amounts receivable within one year:
 Trade receivables                    1,338,899                        994,742                          1,147,709
 Other receivables                    247,225                          10,440                           -
 Financial assets                     1,586,124                        1,005,182                        1,147,709
 Prepayments                          209,511                          65,184                           92,465
                                      1,795,635                        1,070,366                        1,240,174

 

Trade and other receivables do not contain any impaired assets. The Group does
not hold any collateral as security and the maximum exposure to credit risk at
the Consolidated Statement of Financial Position date is the fair value of
each class of receivable.

 

7.       Cash and cash equivalents

                               Unaudited                        Unaudited                      Audited

                                30 June                          30 June                       31 December

                                      2024                             2023                             2023
                                            £                                £                            £
  Cash at bank and in hand   3,920,326                        7,838,889                                  7,714,182
                             3,920,326                        7,838,889                                   7,714,182

 

 

 

8.       Trade and other payables

 

                                  Unaudited               Unaudited               Audited

                                  30 June                 30 June                 31 December

                                           2024                    2023           2023
                                  £                       £                       £
 Trade payables                   404,067                 675,229                 1,006,054
 Social security and other taxes  160,379                 198,032                 71,850
 Contract liability               621,061                 644,110                 3,847,716
 Accrued expenses                 471,784                 677,955                 1,413,914
                                  1,657,291               2,195,326               6,339,534

 

 

 

9.       Related party transactions

Related parties, as defined by IAS 24 'Related Party Disclosures', are the
wholly owned subsidiary companies: Futura Medical Developments Limited and
Futura Consumer Healthcare Limited and the Board. Transactions between the
Company and the wholly owned subsidiary companies have been eliminated on
consolidation and are not disclosed.

 

10.     Taxation

The Group's tax credit in the six months ended 30 June 2024 was £0.14 million
(six months ended 30 June 2023: £0.20 million, year ended 31 December 2023:
£0.38 million). The tax credit balance of £0.14 million relates to
anticipated R&D tax credits in respect of claims not yet submitted 2024
financial year.

 

11.     Share capital

 

 Authorised                         30 June                 30 June                 31 December 2023  30 June                        30 June                        31 December 2023

                                             2024                    2023                                      2024                          2023
                                    Number                  Number                  Number                          £                              £                £
 Ordinary shares of 0.2 pence each  500,000,000             500,000,000             500,000,000       1,000,000                      1,000,000                      1,000,000

 

 

 

 Allotted, called up and fully paid  30 June                 30 June                 31 December 2023  30 June                        30 June                        31 December 2023

                                              2024                    2023                                      2024                           2023
                                     Number                  Number                  Number                          £                              £                £
 Ordinary shares of 0.2 pence each   301,863,641             299,071,457             301,405,950       603,727                        598,143                        602,812

 

 

The number of issued ordinary shares as at 1 January 2024 was 301,405,950.
During the period of six months ended 30 June 2024, the Company issued 457,691
ordinary shares of 0.2 pence with each ordinary share carrying the right to
one vote as follows:

                                                                            £        Number
 January 2024  Non-Executive Director share award at 51.50 pence per share  22,402  43,500
 June 2024     Exercise of share options at 0.2 pence per share             828     414,191
                                                                            23,230  457,691

 

 

12.     Exercise of warrants

 

The balance of the warrant reserve as at 1 January 2023 related to a warrant
instrument issued in January 2020, as part of a wider share issue to raise
funds under a subscription agreement. The Company issued 10,937,500 warrants.
The warrants were issued at a price of 40 pence per ordinary share and were
exercised in full in June 2023, resulting in funds received of £4,375,000. As
a result of this exercise the warrant reserve was transferred to retained
earnings.

 

13.     Share based payments

 

The Black-Scholes formula is the option pricing model applied to the grants of
all share options in the period made in respect of calculating the fair value
of the share options.

 Grant date                           19 April 2024
 Number of shares under option       2,176,000
 Vesting period ends                 April 2027
 Share price as at date of grant     35.50p
 Option exercise price                35.50p
 Expected volatility                 86.63%
 Dividend yield                      0%
 Risk-free investment rate           4.61%
 Exercisable from/to                 April 2027 - March 2034
 Expected life of options             4 years

 Fair value per share at grant date  23.03p

 

 

14.     Post -period balance sheet events

 

There were no post-period balance sheets events.

 

 

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