Interim Results
for the Six Months ended 30 June 2019
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Futura Medical plc Interim Report 2019
www.futuramedical.com
Stock Code: FUM
WHAT WE DO
Futura Medical plc
(AIM: FUM) (“Futura”
or the “Company”),
a pharmaceutical
company developing a
portfolio of innovative
products based on its
proprietary, transdermal
DermaSys® drug
delivery technology
currently focused on
sexual health and pain,
is pleased to announce
its interim results for the
six months ended
30 June 2019.
“ We continue to make good
progress in the development and
commercialisation of our pipeline
of product opportunities. We are
pleased to have completed
recruitment for the double-blind,
clinical efficacy of the first
European Phase 3 study of
MED2005.
We look forward to Phase 3
headline data within four months’
time. Engagement with eminent
experts in the field of erectile
dysfunction continues in both
Europe and the US to increase
awareness as well as with
potential commercial partners in
advance of Phase 3 results which
remain our key priority to deliver
on by the end of 2019”
www.futuramedical.com
CONTENTS
1
2
5
Highlights
Operational Review
Financial Review
6
6
7
Consolidated Statement of
Comprehensive loss
Consolidated Statement of
Changes in Equity
8
9
Consolidated Statement of
Cash Flows
Notes to the Consolidated
Financial Statements
Consolidated Statement of
12
Company Information
Financial Position
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01
HIGHLIGHTS
OPERATIONAL HIGHLIGHTS
FINANCIAL HIGHLIGHTS
MED2005 – Topical glyceryl trinitrate (GTN) formulation
for erectile dysfunction
£4.46 million net loss in the period (30 June 2018:
net loss £1.95 million).
Cash resources of £5.63 million at 30 June 2019 (30 June
2018: £6.03 million).
R&D tax credits of £1.36 million for year ending 2018
received in August (Year ending 2017: £0.94 million)
R&D SPEND
CASH BALANCE
£4.74m
£5.63m
Patient recruitment completed in June 2019 for the
MED2005 first European Phase 3 study “FM57”. This
study is on track to deliver headline efficacy and safety
data by the end of 2019. Patient recruitment was
completed in June 2019 and at the end of August over
500 patients had completed the 12 week double-blind
phase of the study with 80% of these patients having
elected to continue into the open label extension to
study long term safety of the highest dose.
Planning for a second, confirmatory Phase 3 study for
MED2005 is underway.
Positive data to support safety in sexual partners
provided at the European Society of Sexual Medicine
(ESSM) congress in February 2019, including a review of
safety data from the Phase 2a study, pharmacokinetic
study and in-vitro impedance data.
Second advisory panel held at ESSM in Slovenia in
February 2019 with prominent European key opinion
leaders (KOLs) to review the data and discuss the
on-going development and educational programme.
As with US KOLs, their reaction to the therapeutic
potential for MED2005 in erectile dysfunction and its
areas of differentiation as well as the ongoing clinical
programme was highly positive reflecting the limited
amount of innovation in the sector for over ten years.
TPR100 – Topical non-steroidal anti-inflammatory for
the pain and inflammation associated with sprains,
strains and bruises and soft tissue rheumatism
UK partner Thornton & Ross (a subsidiary of STADA AG)
received feedback from UK Medicines and Healthcare
products Regulatory Agency (MHRA) in February 2019
requiring additional laboratory work to be conducted to
support the UK filing. This work is progressing, and we
expect to respond in Q1 2020 within the timelines
agreed with the MHRA.
Ongoing commercial discussions with several potential
distribution partners for other territories. Any further
licensing deals are expected to be after UK regulatory
approval.
CBD100 – Joint Venture Collaboration on optimised
topical delivery of Cannabidiol
Joint venture collaboration with CBDerma Technology
Limited to explore the application of DermaSys® for
optimised delivery of Cannabidiol through the skin to
explore a number of disease states including pain relief.
The initial joint venture development costs are expected
to be in the region of $1 million. Any Intellectual Property
will be jointly owned.
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STRATEGIC REPORT 02
OPERATIONAL REVIEW
MED2005 – Topical gel for erectile
dysfunction (“ED”)
Futura’s lead product MED2005 is a
topical glyceryl trinitrate (GTN) gel for
the treatment of erectile dysfunction
(ED). MED2005 has the potential to
be a highly differentiated therapy,
especially for mild to moderate ED.
In a Phase 2a study, MED2005 was
shown to have a fast onset of action
(5-10 minutes) and rapid clearance.
MED2005 has the potential to be the
fastest-acting ED treatment available.
Erectile dysfunction disrupts the lives
of at least 1 in 5 men globally1, affecting
the sexual and emotional health of
around 27 million men and their
partners in the USA alone. There has
been little innovation in ED treatments
for over ten years and many patients
continue to suffer dissatisfaction with
existing treatments especially those
looking for a fast-acting treatment that
can form part of sexual foreplay or
those patients that are contraindicated
from using existing therapies2.
Recent focus group research conducted
by Futura in the UK on pre and post-
menopausal women with partners with
erectile dysfunction showed strong
interest in MED2005 and its unique
attributes. In particular it highlighted the
perceived benefit of MED2005
providing a shared sexual experience
with the potential to take the
responsibility of treatment away from
their male partner alone towards a
solution that is embraced by the couple
together. KOLs have consistently said
treating the couple is more effective
than treating the individual.
With an independently assessed
market potential of over $1 billion
as a prescription treatment and
subsequently over the counter (OTC)
treatment3, MED2005 is Futura’s lead
asset and a key value creation
opportunity.
JAMES BARDER
Chief Executive
“ Building for
the future”
As an innovative, specialist
R&D company, Futura’s
strategy is to leverage its
DermaSys® transdermal
delivery technology to
bring innovative products
to market in sexual health
and pain, bringing new
treatment options to
patients particularly in
areas of significant
unmet need.
1. EMEA, Withdrawal assessment report for
Viagra, 2008
2. 50% of men discontinue treatment on
PDE5s, reference Carvalheira J Sex Med.
2012 Sep;9(9):2361-9. Research from Decision
Resources Group and Cello Health
Consulting show that many patients are
dissatisfied with their treatment. In the
research from Cello, physicians stated that
the main reason they see their patients
switch to MED2005 is the speed of onset.
3. Based on external market assessments from
market research conducted by Cello Health
Consulting as a prescription product and
Ipsos Group as an over the counter product.
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Stock Code: FUMwww.futuramedical.comFutura Medical plc Interim Report 2019 03
Phase 3 clinical programme
progressing well
“FM57” – First, European Phase 3
MED2005’s first Phase 3 study, “FM57”
completed patient recruitment in June
2019. The 1,000 patient study includes
approximately 60 centres across
Central and Eastern Europe. Futura
remains on track to deliver first Phase 3
headline data by the end of 2019.
This Phase 3 study is a dose ranging,
randomised, double blind, placebo
controlled, home use, parallel group
clinical trial and compares the efficacy
of 0.2%, 0.4% and 0.6% GTN doses of
MED2005 in mild, moderate and
severe ED patients.
Following positive Phase 2a “FM53”
data, we have confidence that the
higher doses of 0.4% and 0.6% being
studied in addition to the 0.2% dose
will show improved efficacy across
patients with mild, mild to moderate
and moderate ED – which represent
the large majority of ED sufferers
throughout the world and the largest
commercial opportunity. Severe ED
patients, who often have the most
medical complications as well as
being the oldest men, are a difficult
patient cohort to treat. This is further
evidenced by the limited success of
the existing ED treatments in this
cohort. We therefore remain cautious
over the potential benefit MED2005
will bring to severe patients. As the
first Phase 3 includes patients of all
ED severities, if reduced efficacy in
severe ED patients occurs, it is not
expected to compromise the overall
success of the study.
KOLs in both US and EU have
expressed strong interest in a locally
acting, fast and safe new treatment
for ED that particularly targets those
younger patients with mild and mild
to moderate ED where frequency of
intercourse is generally high
compared to those patients with
moderate to severe ED.
As part of the Phase 3 programme,
Futura is required by regulators to run
an open label extension study for
safety. After patients complete their
4-month trial period, they are invited
to enter the open label extension
study (“OLE”) to assess safety at the
highest dose (0.6% GTN) up to the
required number of 450 patients.
Of these patients 300 are to continue
treatment for a further 6 months and
150 patients for a further 12 months.
At the end of August 500 patients had
completed the 12 week double-blind
phase of the study with 80% of these
patients having elected to continue
into the open label extension to study
long term safety of the highest dose.
This OLE is a normal requirement of
regulators for pharmaceutical
products to provide additional
reassurance on safety for longer
term use of MED2005.
“FM59” – Second confirmatory
Phase 3
We anticipate patient enrolment to
commence for “FM59”, a second,
confirmatory Phase 3 study for
MED2005 in H1 2020.
This study will incorporate a US patient
cohort and we will be shortly filing
protocols and an Investigational New
Drug Application (IND) in the US.
The protocols for this study will be the
same as for “FM57” initially but will be
informed by the receipt and analysis of
the first Phase 3 data and adapted
accordingly, if necessary, via regulatory
amendments. The second Phase 3 will
be a placebo controlled, parallel group
study and will compare the efficacy of
two GTN doses of MED2005, shown to
be optimal in the first Phase 3 trial, in a
smaller patient cohort of around 700
patients. The Company is currently
undertaking pre-recruitment start-up
activities in order to commence
patient enrolment in H1 2020.
Completion of the second,
confirmatory Phase 3 study, expected
by the end of 2020, is subject to
funding and positive results from
“FM57”, the first European Phase 3
trial. Any financing is expected to
depend on the strength of the results
in FM57. In anticipation of this, the
Board is therefore exploring both
non-dilutory and dilutory funding
options and intends to place the
Company in a position of strength to
continue capitalising on product
development and for negotiating any
out-licensing agreements for
MED2005.
It is usual for two Phase 3 studies to
be required for regulatory filing.
However, depending on data from
the first European Phase 3 study,
Futura may explore filing MED2005
with regulatory bodies in Europe with
one Phase 3 study which could occur
during H2 2020. The US FDA has been
clear that two studies are required,
and filing will await results from the
second Phase 3 study.
Futura held a R&D analyst event held
in London in February 2019 including
a presentation from Professor David
Ralph, a world leading expert in
erectile dysfunction and male
infertility and Chair of the Futura
Medical European Advisory Panel.
These activities and events organised
by Futura are continuing to increase
the awareness and credibility of the
potential innovation that MED2005
brings within the treatment arena of
ED to both the medical and
pharmaceutical communities.
A second US advisory board meeting
has been arranged for October 2019
at the Sexual Medicine Society of
North America Conference.
Discussions continue with a number
of interested commercial partners for
the out-licensing of MED2005
although the Company’s main focus
is to deliver Phase 3 headline data by
the end of 2019 and prepare for the
second smaller Phase 3 which is
critical for US regulatory approval in
order to bring MED2005’s novel
benefits to ED patients through the
EU and US as soon as possible.
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STRATEGIC REPORT Initial development costs are
expected to be in the region of
US$ 1 million and will cover all
development costs incurred by the
Company during the next 15 months
in order to develop and optimise a
DermaSys® cannabidiol formulation
as well as establish early ex-vivo proof
of concept studies likely to include
certain disease states most suited for
local or regional (non-systemic)
topical treatment such as pain relief.
The Company does not expect this
project’s initial development to have
any material impact on cashflow as
Futura’s financial share of the project
will be delivered from its expertise
and existing internal resources.
DermaSys® provides rapid and
targeted local delivery of active
pharmaceutical ingredients at
therapeutic levels through the skin to
the required site of action with a high
level of safety. It is a versatile and
bespoke technology that can be
tailored to suit the specific active
compound being used and the
therapeutic indication. Each product
is formulated to maximise its benefits
for patients and consumers and can
be developed for the prescription and
consumer healthcare markets as
appropriate.
JAMES BARDER
Chief Executive
04
We believe MED2005 has the
required efficacy, speed of onset and
favourable safety profile consistent
with use as a prescription therapy as
well as the potential to be an over-
the-counter therapy.
MED2005 Intellectual Property
MED2005’s current patent protection
runs until August 2028 in the USA and
August 2025 in Europe. In August 2018
Futura filed a Patent Co-operation Treaty
(PCT) patent filing which is expected to
extend patent life in many geographies
to 2038. The PCT filing will be moving
into the National filing phase in Q1 2020
in line with standard processes. This
phase sets out specific, nominated
countries under the Patent Co-operation
Treaty which will adhere to the 2018
priority date through to 2037.
The EU also can provide up to ten year
data exclusivity and US up to three
years from the date of regulatory
approval subject to EU and FDA
guidelines.
TPR100 – Topical gel for pain relief
TPR100 is a topical non-steroidal
anti-inflammatory for the treatment
of pain and inflammation associated
with sprains, strains, bruises and soft
tissue rheumatism.
TPR100 is partnered for manufacturing
and distribution in the UK with
Thornton & Ross, one of the UK’s
largest consumer healthcare
companies and a subsidiary of STADA
AG. In February 2019, the UK
Medicines and Healthcare products
Regulatory Agency (MHRA) responded
to Thornton & Ross’s marketing
authorisation application filed in July
2018, raising a number of questions
requiring additional lab work
specifically around the permeation
characteristics of TPR100 to be
conducted. This work is progressing,
and we expect Thornton & Ross to
respond by the end of February 2020
within the timelines agreed with
the MHRA.
The Company has received
expressions of interest from a number
of parties to enable Futura to expand
the geographical reach of TPR100.
Futura is awaiting regulatory
authorisation in the UK before
progressing further with these
discussions.
CBD100 – Joint Venture
Collaboration on optimised topical
delivery of Cannabidiol
A joint venture collaboration has been
signed with CBDerma Technology
Limited to explore the application of
Futura’s advanced proprietary
transdermal drug delivery technology,
DermaSys® for delivery of Cannabidiol.
All Intellectual Property will be owned
jointly by the Company and CBDerma
Technology Limited.
CBDerma Technology is a company
that has been established and funded
to specifically exploit the therapeutic
potential of Cannabis. The company’s
management, backers and advisors
have extensive knowledge, expertise
and investments in plant derived
product manufacturing. Cannabidiol
is a major component of the cannabis
plant and is generally regarded as
non-addictive and non-psychoactive,
making it ideal for consideration as a
topically delivered molecule for local
or regional (non-systemic) use.
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Stock Code: FUMwww.futuramedical.comFutura Medical plc Interim Report 2019 FINANCIAL REVIEW
05
ANGELA HILDRETH
Finance Director and Chief Operating Officer
Research and
Development Costs
Research and Development
costs for the six months
ended 30 June 2019 were
£4.74 million, compared to
£1.65 million for the six
months ended 30 June
2018. The increase of £3
million is attributable to the
FM57 Phase 3 study which
is running on time, within
budget and expected to
provide headline data in
December 2019.
Taxation
The tax credit of £0.8 million (2018:
£0.6m) is an accrual for the expected
R&D tax credit receivable for the six
months ended 30 June 2019.
Post Period Events
The R&D tax credit relating to 2018
claim of £1.36 million was received
in August 2019.
Outlook
Futura now has the potential for a
significant value inflection driven by
MED2005 late stage clinical
development. We look forward to
headline data from the first Phase 3
study towards the end of 2019. We are
excited to be moving closer to
bringing an innovative, highly
differentiated ED product to market
that could help the many ED patients
whose needs are not met by current
treatments. In parallel we are
managing the Company’s resources
prudently whilst planning and
building for the future to further
leverage our DermaSys® technology
and products.
Administrative Costs
Administrative costs were £0.53
million for the six months ended
30 June 2019 compared to £0.86
million for the six months ended 30
June 2018 and were reflective of the
Company’s strategy to keep central
costs lean and focus cash resources
on delivering the R&D programme.
Going Concern
At the period end the Group held
£5.63 million of cash with a further
£1.36 million of R&D tax credit refund
received after the period end, in
August 2019. As has been previously
discussed, the cash currently held by
the Group will not be sufficient to
complete the second Phase 3 study
(FM59) which the Group intends to
commence during 2020, assuming
that the results of FM57 are positive.
The Board is therefore exploring a
number of funding options including
non-dilutory and dilutory options and
believe that the results of the FM57
trial will have a major impact on these
funding options and the costs
associated with them. Whilst there
can be no guarantee that any of these
opportunities will be successfully
concluded, the Directors believe that
it remains appropriate to prepare the
financial statements on a going
concern basis.
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STRATEGIC REPORT 0606
CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS
FOR THE SIX MONTHS ENDED 30 JUNE 2019
Revenue
Research and development costs
Administrative costs
Operating loss
Finance income
Loss before tax
Taxation
Total comprehensive loss for the period attributable
to owners of the parent company
Loss per share (pence)
Unaudited
6 months
ended
30 June
2019
£
–
(4,739,965)
(534,545)
(5,274,510)
13,395
(5,261,115)
800,000
Unaudited
6 months
ended
30 June
2018
£
Audited
year
ended
31 December
2018
£
–
–
(1,652,536)
(6,038,941)
(866,132)
(1,227,547)
(2,518,668)
(7,266,488)
9,429
27,576
(2,509,239)
(7,238,912)
558,557
1,358,336
(4,461,115)
(1,950,682)
(5,880,576)
(2.18p)
(1.61p)
(4.46p)
Notes
9
5
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHS ENDED 30 JUNE 2019
Share
Capital
£
Share
Premium
£
Merger
Reserve
£
Retained
Losses
£
Total
Equity
£
At 1 January 2018 - audited
241,392
44,671,396
1,152,165
(36,959,195)
9,105,758
Total comprehensive loss for the period
Share-based payment
Shares issued during the period
At 30 June 2018 - unaudited
Total comprehensive loss for the period
Share-based payment
Shares issued during the period
At 31 December 2018 - audited
Total comprehensive loss for the period
Share-based payment
Shares issued during the period
At 30 June 2019 - unaudited
–
–
–
–
620
92,380
–
–
–
(1,950,682)
(1,950,682)
103,464
–
103,464
93,000
242,012
44,763,776
1,152,165
(38,806,413)
7,351,540
–
–
–
–
167,155
5,220,084
–
–
–
(3,929,894)
(3,929,894)
43,369
43,369
–
5,387,239
409,167
49,983,860
1,152,165 (42,692,938)
8,852,254
–
–
154
–
–
19,130
–
–
–
(4,461,115)
(4,461,115)
41,724
–
41,724
19,284
409,321 50,002,990
1,152,165
(47,112,329)
4,452,147
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Stock Code: FUMwww.futuramedical.comFutura Medical plc Interim Report 2019Stock Code: FUMwww.futuramedical.comFutura Medical plc Interim Report 2019 CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AT 30 JUNE 2019
0707
Assets
Non-current assets
Plant and equipment
Total non-current assets
Current assets
Inventories
Trade and other receivables
Current tax asset
Cash and cash equivalents
Total current assets
Liabilities
Current liabilities
Trade and other payables
Total liabilities
Total net assets
Capital and reserves attributable to owners
of the parent company
Share capital
Share premium
Merger reserve
Retained losses
Total equity
Unaudited
30 June
2019
£
Unaudited
30 June
2018
£
Audited
31 December
2018
£
Notes
71,800
71,800
55,681
55,681
47,473
47,473
6
7
7,780
122,887
2,158,192
5,626,792
7,915,651
70,413
152,049
1,485,803
6,025,174
7,780
306,408
1,358,192
9,157,916
7,733,439
10,830,296
(3,535,304)
(3,535,304)
4,452,147
(437,580)
(437,580)
7,351,540
(2,025,515)
(2,025,515)
8,852,254
409,321
242,012
409,167
50,002,990
44,763,776
49,983,860
1,152,165
1,152,165
1,152,165
(47,112,329)
(38,806,413)
(42,692,938)
4,452,147
7,351,540
8,852.254
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STRATEGIC REPORTFINANCIALS 0808
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHS ENDED 30 JUNE 2019
Cash flows from operating activities
Loss before tax
Adjustments for:
Depreciation
Loss on disposal of fixed assets
Finance income
Share-based payment charge
Cash flows from operating activities before
changes in working capital
Decrease in inventories
(Increase)/decrease in trade and other receivables
(Decrease)/increase in trade and other payables
Cash used in operations
Income tax received
Net cash used in operating activities
Cash flows from investing activities
Purchase of plant and equipment
Interest received
Cash (absorbed)/generated by investing activities
Cash flows from financing activities
Issue of ordinary shares
Expenses paid in connection with share issue
Cash generated by financing activities
Unaudited
6 months
ended
30 June
2019
£
Unaudited
6 months
ended
30 June
2018
£
Audited
year
ended
31 December
2018
£
(5,261,115)
(2,509,239)
(7,238,912)
7,860
9,935
(13,395)
41,724
(9,429)
103,464
19,850
703
(27,576)
146,833
(5,224,926)
(2,405,269)
(7,099,102)
–
183,522
1,509,788
(3,531,617)
–
29,027
(61,561)
62,633
(125,332)
1,526,375
(2,437,803)
(5,635,426)
–
–
927,391
(3,531,617)
(2,437,803)
(4,708,035)
(32,186)
13,395
(18,791)
19,284
-
19,284
(2,099)
9,429
7,330
(4,510)
27,576
(23,066)
93,000
5,943.421
-
(463,182)
93,000
5,480,239
(Decrease)/increase in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
(3,531,124)
(2,337,472)
9,157,916
5,626,792
8,362,646
6,025,174
795,270
8,362,646
9,157,916
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Stock Code: FUMwww.futuramedical.comFutura Medical plc Interim Report 2019Stock Code: FUMwww.futuramedical.comFutura Medical plc Interim Report 2019 0909
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 JUNE 2019
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, 2019 were authorised for issue in accordance with a resolution of the Directors on 10th
September, 2019. 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 of pharmaceutical and healthcare products.
2. ACCOUNTING POLICIES
The accounting policies applied in these interim statements are consistent with those of the annual financial statements
for the year end 31 December 2018, as described in those financial statements except for the new accounting policies
described in accounting developments below.
These condensed interim consolidated financial statements for the six months ended 30 June 2019 and for the six
months ended 30 June 2018 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 2018 has been extracted from the financial
statements of the statutory accounts (“Annual Report”) of Futura Medical plc, which were prepared in accordance with
International Financial Reporting Standards (“IFRSs”) as adopted by the European Union and International Financial
Reporting Interpretations Committee (“IFRIC”) interpretations that were applicable for the year ended 31 December 2018
and does not constitute the full statutory accounts for that period. The Annual Report for 2018 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 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.
ACCOUNTING DEVELOPMENTS
The Directors have considered all new standards, amendments to standards and interpretations which are mandatory
for the first time for the financial year beginning 1 January 2019. From 1 January 2019 the Company adopted IFRS 16
Leases and concluded that the adoption of IFRS 16 does not have a material impact on the Group’s consolidated
statements and requires no transitional adjustments to be made.
3. CRITICAL ACCOUNTING JUDGEMENTS, ASSUMPTIONS AND ESTIMATES
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 loss after tax for the six months ended 30 June 2019 of £4.46 million (six months ended 30
June 2018: £1.95 million, year ended 31 December 2018: £5.88 million). The Group holds cash balances of £5.63 million at
30 June 2019 (30 June 2018: £6.03 million, 31 December 2018: £9.16 million).
The Directors have prepared a detailed forecast to 31 December 2021 based on current plans. The forecast assumes
both committed costs and future planned discretionary spend and the Directors consider that they will have sufficient
cash resources to settle all committed costs and discretionary costs for at least 12 months from the date of approval of
these financial statements. The forecasts also assume that the group will be able to raise additional sources of finance to
fund future expenditure if the results of the MED2005 trial are positive.
It should be noted that the forecasts do not include any cash receipts from future MED2005 out-licensing agreements
or other forms of funding that the Directors are actively considering, and which the Directors believe, from previous and
ongoing discussions will result in material cashflow into the business during the detailed forecast period to 31 December
2021.
The Directors continue to monitor the levels of discretionary spend and have the ability to delay certain costs, such as
Research and Development expenditure, in the event of unforeseen cash constraints or delayed cash receipts.
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STRATEGIC REPORTFINANCIALS 1010
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 JUNE 2019
3. CRITICAL ACCOUNTING JUDGEMENTS, ASSUMPTIONS AND ESTIMATES CONTINUED
GOING CONCERN CONTINUED
The Directors have also considered a scenario where the Phase 3 results of the MED2005 trial are not successful,
although this scenario is considered to be highly unlikely. In this scenario the Directors will have sufficient cash to meet
and settle all the committed expenditure and have sufficient cash to re-align their business strategy and continue
investment in other products within their pipeline. The cash balances will be sufficient to cover at least 12 months from
the date of signing the financial statements.
The Directors, having reviewed the Group’s and Company’s budgets and plans, taking account of reasonably possible
changes in trading performance, have a reasonable expectation that the Group and the Company have adequate
resources to continue in operational existence for the foreseeable future (being at least 12 months from the date of
approval of these financial statements) and that it is therefore appropriate to continue to adopt the going concern basis
in preparing the financial statements.
Based on the above, the Directors believe that it remains appropriate to prepare the financial statements on a going
concern basis. However, they acknowledge there exists a material uncertainty over the Group’s ability to access
additional sources of finance which may be dependent upon the outcome of the MED2005 trial - that may cast
significant doubt on the Group’s and Company’s ability to continue as a going concern and, therefore, to continue
realising its assets and discharging its liabilities in the normal course of business. The financial statements do not
include any adjustments that would result from the basis of preparation being inappropriate.
ESTIMATES AND ASSUMPTIONS
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 require the use of estimation.
JUDGEMENTS
Deferred tax recognition
The determination of probable future profits, against which the Group’s deferred tax profits can be offset, requires
judgement.
4. SEGMENT REPORTING
There was no revenue reported in the six months ended 30 June 2019 or in the comparator period therefore, there is no
segmental information to report in respect of turnover.
5. LOSS PER SHARE (PENCE)
The calculation of the loss per share is based on a loss of £4,461,115 (six months ended 30 June 2018: loss of £1,950,682;
year ended 31 December 2018: loss of £5,880,576) and on a weighted average number of shares in issue of 204,655,173
(six months ended 30 June 2018: 120,959,395; year ended 31 December 2018: 131,936,761). The loss attributable to equity
holders of the Company for the purpose of calculating 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
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’.
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Stock Code: FUMwww.futuramedical.comFutura Medical plc Interim Report 2019Stock Code: FUMwww.futuramedical.comFutura Medical plc Interim Report 2019 1111
6. TRADE AND OTHER RECEIVABLES
Amounts receivable within one year:
Trade receivables
Other receivables
Prepayments and accrued income
Unaudited
30 June
2019
£
Unaudited
30 June
2018
£
Audited
31 December
2018
£
627
63,604
58,656
122,887
627
23,253
128,168
152,049
627
247,799
57,982
306,408
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
Cash at bank and in hand
Sterling fixed rate short-term deposits
Unaudited
30 June
2019
£
Unaudited
30 June
2018
£
Audited
31 December
2018
£
2,162,364
186,097
3,464,428
5,839,077
5,626,792
6,025,174
5,706,519
3,451,397
9,157,916
8. 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.
9. TAXATION
The Group’s tax credit in the six months ended 30 June 2019 was £0.8 million (six months ended 30 June 2018: £0.55m,
year ended 31 December: £1.36 million). The current period tax credit relates to anticipated R&D tax credits in respect of
claims not yet submitted for the 2019 financial year.
10. SUBSEQUENT EVENTS
In August 2019, the Group received the 2018 R&D tax credit of £1.36m.
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STRATEGIC REPORTFINANCIALS 1212
COMPANY INFORMATION
COMPANY NUMBER
04206001
DIRECTORS
John Clarke
James Barder
Angela Hildreth
Jonathan Freeman
Ken James
Non-Executive Chairman
Chief Executive
Finance Director and Chief Operating Officer
Non-Executive Director
Head of R&D and Executive Director
AUDIT COMMITTEE
Jonathan Freeman
John Clarke
REMUNERATION COMMITTEE
Jonathan Freeman
John Clarke
NOMINATIONS COMMITTEE
John Clarke
Jonathan Freeman
SECRETARY AND
REGISTERED OFFICE
Angela Hildreth
Futura Medical plc
Surrey Technology Centre
40 Occam Road
Guildford
Surrey
GU2 7YG
NOMINATED ADVISER AND
BROKER
Liberum
25 Ropemaker Street
London
EC2Y 9LY
AUDITOR
KPMG LLP
Arlington Business Park
Theale
Reading
Berkshire
RG7 4SD
REGISTRAR
Link Asset Services
34 Beckenham Road
Beckenham
Kent
BR3 4TU
PATENT ATTORNEY
Withers & Rogers LLP
4 More London Riverside
London
SE1 2AU
PUBLIC RELATIONS ADVISER
Optimum Strategic Communications
8 Devonshire Square
London
EC2M 4YF
PRINCIPAL SOLICITOR
Square One Law
Burdon Terrace,
Newcastle upon Tyne
NE2 3AE
PRINCIPAL BANKER
HSBC Bank
12A North Street
Guildford
GU1 4AF
INVESTMENT MANAGER
Royal London Asset Management
Limited
PO Box 9035
Chelmsford
CM99 2XB
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Stock Code: FUMwww.futuramedical.comFutura Medical plc Interim Report 2019Stock Code: FUMwww.futuramedical.comFutura Medical plc Interim Report 2019
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Futura Medical plc
Surrey Technology Centre
40 Occam Road
Guildford
Surrey
GU2 7YG
Tel: +44 (0) 1483 685 670
Fax: +44 (0) 1483 685 671
Email: info@futuramedical.com
Web: www.futuramedical.com
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