TIDMFUM
RNS Number : 8860L
Futura Medical PLC
11 September 2019
For immediate release
11 September 2019
Futura Medical plc
("Futura" or "the Company")
Interim Results for the Six Months ended 30 June 2019
Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a
pharmaceutical company developing a portfolio of innovative
products based on its proprietary, transdermal DermaSys(R) 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.
Highlights
MED2005 - Topical glyceryl trinitrate (GTN) formulation for
erectile dysfunction
-- 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(R) 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.
Financial highlights
-- GBP4.46 million net loss in the period (30 June 2018: net loss GBP1.95 million).
-- Cash resources of GBP5.63 million at 30 June 2019 (30 June 2018: GBP6.03 million).
-- R&D tax credits of GBP1.36 million for year ending 2018 received in August (Year ending 2017: GBP0.94 million)
James Barder, Chief Executive of Futura, commented: "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. Most patients have
elected to continue into the open-label, Phase 3, safety stage in
which all patients are on the highest dose of MED2005. We look
forward to Phase 3 headline data by the end of the year. 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."
Analyst meeting and webcast
The Executive Team will host a presentation at 10am (BST), 11
September 2019, for analysts at the office of Liberum Capital at 25
Ropemaker Street, London, EC2Y 9LY. Analysts wishing to attend the
presentation should register their interest by emailing
futuramedical@optimumcomms.com.
Following the results meeting, a webcast of the presentation
will also be made available within the Investor Centre section of
the Futura company website at www.futuramedical.com.
For further information please contact:
Futura Medical plc
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Email: Investor.relations@futuramedical.com
Tel: +44 (0) 1483 685 670
Nominated Adviser and Sole Broker:
Liberum
Bidhi Bhoma/ Euan Brown/ Kane Collings
Tel: +44 (0) 203 100 2000
For media enquiries please contact:
Optimum Strategic Communications
Mary Clark/ Eva Haas/ Hollie Vile
Email: futuramedical@optimumcomms.com
Tel: +44 (0) 203 950 9144
Notes to editors:
About Futura Medical plc
Futura Medical plc (AIM: FUM), is a pharmaceutical company
developing a portfolio of innovative products based on its
proprietary, transdermal DermaSys(R) drug delivery technology.
These products are optimised for clinical efficacy, safety,
administration and patient convenience and are developed for the
prescription and consumer healthcare markets as appropriate.
Current therapeutic areas are sexual health, including erectile
dysfunction, and pain relief. Development and commercialisation
strategies are designed to maximise product differentiation and
value creation whilst minimising risk.
The first European Phase 3 study for MED2005, referred to as
"FM57", is a 1,000 patient, dose-ranging, multi-centre, randomised,
double blind, placebo-controlled, home use, parallel group study of
MED2005 0.2%, 0.4% and 0.6% Glyceryl Trinitrate for the treatment
of erectile dysfunction with a 450 patient open label extension.
FM57 is progressing on track, with headline data expected by the
end of 2019.
Futura is based in Guildford, Surrey, and its shares trade on
the AIM market of the London Stock Exchange.
www.futuramedical.com
Operational Review - "Building for the future"
As an innovative, specialist R&D company, Futura's strategy
is to leverage its DermaSys(R) 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.
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
globally(1) , 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 contraindicated from
using existing therapies(2) .
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) treatment(3) , MED2005 is Futura's lead asset and a
key value creation opportunity.
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 US filing will await results from the second
Phase 3 study.
Futura held a R&D analyst event 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.
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's 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 laboratory 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(R) 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.
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(R) - 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(R) 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.
Financial Review
Research and Development Costs
Research and Development costs for the six months ended 30 June
2019 were GBP4.74 million, compared to GBP1.65 million for the six
months ended 30 June 2018. The increase of GBP3 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.
Administrative Costs
Administrative costs were GBP0.53 million for the six months
ended 30 June 2019 compared to GBP0.86 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 GBP5.63 million of cash with a
further GBP1.36 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.
Taxation
The tax credit of GBP0.8 million (2018: GBP0.6m) 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 GBP1.36 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(R) technology and products.
References
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.
Consolidated Statement of Comprehensive loss
For the six months ended 30 June 2019
Unaudited Unaudited Audited
6 months 6 months ended year
ended 30 June ended
30 June 2018 31 December
2019 2018
Notes GBP GBP GBP
Revenue - - -
Research and development costs (4,739,965) (1,652,536) (6,038,941)
Administrative costs (534,545) (866,132) (1,227,547)
Operating loss (5,274,510) (2,518,668) (7,266,488)
Finance income 13,395 9,429 27,576
Loss before tax 5,261,115) (2,509,239) (7,238,912)
Taxation 9 800,000 558,557 1,358,336
------------------------------- ------- ---------------------- ---------------------- ------------------------
Total comprehensive loss for
the period attributable to
owners
of the parent company (4,461,115) (1,950,682) (5,880,576)
------------------------------- ------- ---------------------- ---------------------- ------------------------
Loss per share (pence) 5 (2.18p) (1.61p) (4.46p)
------------------------------- ------- ---------------------- ---------------------- ------------------------
Consolidated Statement of Changes in Equity
For the six months ended 30 June 2019
Share Share Merger Retained Total
Capital Premium Reserve Losses Equity
GBP GBP GBP GBP GBP
--------------- ---
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 - - - (1,950,682) (1,950,682)
Share-based
payment - - - 103,464 103,464
Shares issued
during
the period 620 92,380 - - 93,000
At 30 June 2018
- unaudited 242,012 44,763,776 1,152,165 (38,806,413) 7,351,540
--------------- --- ------------------ ------------------- ----------------- ------------------- -------------------
Total
comprehensive
loss for the
period - - - (3,929,894) (3,929,894)
Share-based
payment - - - 43,369 43,369
Shares issued
during
the period 167,155 5,220,084 - - 5,387,239
At 31 December
2018
- audited 409,167 49,983,860 1,152,165 (42,692,938) 8,852,254
--------------- --- ------------------ ------------------- ----------------- ------------------- -------------------
Total
comprehensive
loss for the
period - - - (4,461,115) (4,461,115)
Share-based
payment - - - 41,724 41,724
Shares issued during
the period 154 19,130 - - 19,284
At 30 June 2019
- unaudited 409,321 50,002,990 1,152,165 (47,112,329) 4,452,147
--------------- --- ------------------ ------------------- ----------------- ------------------- -------------------
Consolidated Statement of Financial Position
At 30 June 2019
Unaudited Unaudited Audited
30 June 30 June 31 December
2019 2018 2018
Notes GBP GBP GBP
Assets
Non-current assets
Plant and equipment 71,800 55,681 47,473
Total non-current
assets 71,800 55,681 47,473
---------------------------- ----- ------------------ ------------------ ----------------
Current assets
Inventories 7,780 70,413 7,780
Trade and other receivables 6 122,887 152,049 306,408
Current tax asset 2,158,192 1,485,803 1,358,192
Cash and cash equivalents 7 5,626,792 6,025,174 9,157,916
---------------------------- ----- ------------------ ------------------ ----------------
Total current assets 7,915,651 7,733,439 10,830,296
---------------------------- ----- ------------------ ------------------ ----------------
Liabilities
Current liabilities
Trade and other payables (3,535,304) (437,580) (2,025,515)
---------------------------- ----- ------------------ ------------------ ----------------
Total liabilities (3,535,304) (437,580) (2,025,515)
---------------------------- ----- ------------------ ------------------ ----------------
Total net assets 4,452,147 7,351,540 8,852,254
---------------------------- ----- ------------------ ------------------ ----------------
Capital and reserves
attributable to
owners of the parent
company
Share capital 409,321 242,012 409,167
Share premium 50,002,990 44,763,776 49,983,860
Merger reserve 1,152,165 1,152,165 1,152,165
Retained losses (47,112,329) (38,806,413) (42,692,938)
---------------------------- ----- ------------------ ------------------ ----------------
Total equity 4,452,147 7,351,540 8,852.254
---------------------------- ----- ------------------ ------------------ ----------------
Consolidated Statement of Cash Flows
For the six months ended 30 June 2019
Unaudited Unaudited Audited
6 months 6 months year
ended ended ended
30 June 30 June 31 December
2019 2018 2018
GBP GBP GBP
Cash flows from operating activities
Loss before tax (5,261,115) (2,509,239) (7,238,912)
Adjustments for:
Depreciation 7,860 9,935 19,850
Loss on disposal of fixed assets 703
Finance income (13,395) (9,429) (27,576)
Share-based payment charge 41,724 103,464 146,833
------------------------------------------ ---------------------- -------------------- --------------------
Cash flows from operating activities
before changes
in working capital (5,224,926) (2,405,269) (7,099,102)
------------------------------------------ ---------------------- -------------------- --------------------
Decrease in inventories - - 62,633
(Increase) / decrease in trade and
other receivables 183,522 29,027 (125,332)
(Decrease) / increase in trade and
other payables 1,509,788 (61,561) 1,526,375
------------------------------------------ ---------------------- -------------------- --------------------
Cash used in operations (3,531,617) (2,437,803) (5,635,426)
------------------------------------------ ---------------------- -------------------- --------------------
Income tax received - - 927,391
------------------------------------------ ---------------------- -------------------- --------------------
Net cash used in operating activities (3,531,617) (2,437,803) (4,708,035)
------------------------------------------ ---------------------- -------------------- --------------------
Cash flows from investing activities
Purchase of plant and equipment (32,186) (2,099) (4,510)
Interest received 13,395 9,429 27,576
Cash (absorbed ) / generated by investing
activities (18,791) 7,330 (23,066)
------------------------------------------ ---------------------- -------------------- --------------------
Cash flows from financing activities
Issue of ordinary shares 19,284 93,000 5,943.421
Expenses paid in connection with share
issues - - (463,182)
Cash generated by financing activities 19,284 93,000 5,480,239
------------------------------------------ ---------------------- -------------------- --------------------
(Decrease) / increase in cash and
cash equivalents (3,531,124) (2,337,472) 795,270
Cash and cash equivalents at beginning
of period 9,157,916 8,362,646 8,362,646
------------------------------------------ ---------------------- -------------------- --------------------
Cash and cash equivalents at end of
period 5,626,792 6,025,174 9,157,916
------------------------------------------ ---------------------- -------------------- --------------------
Notes to the Consolidated Interim 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 GBP4.46 million (six months ended 30 June 2018:
GBP1.95 million, year ended 31 December 2018: GBP5.88 million). The
Group holds cash balances of GBP5.63 million at 30 June 2019 (30
June 2018: GBP6.03 million, 31 December 2018: GBP9.16 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.
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.
3.1 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.
3.2 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
GBP4,461,115 (six months ended 30 June 2018: loss of GBP1,950,682;
year ended 31 December 2018: loss of GBP5,880,576) 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'.
6. Trade and other receivables
Unaudited Unaudited Audited
30 June 30 June 31 December
2019 2018 2018
GBP GBP GBP
Amounts receivable within one year:
Trade receivables 627 627 627
Other receivables 63,604 23,253 247,799
Prepayments and accrued income 58,656 128,168 57,982
------------------------------------ ----------------- ----------------- ----------------
122,887 152,049 306,408
------------------------------------ ----------------- ----------------- ----------------
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
Unaudited Unaudited Audited
30 June 30 June 31 December
2019 2018 2018
GBP GBP GBP
Cash at bank and in hand 2,162,364 186,097 5,706,519
Sterling fixed rate short-term
deposits 3,464,428 5,839,077 3,451,397
5,626,792 6,025,174 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
GBP0.8 million (six months ended 30 June 2018: GBP0.55m, year ended
31 December: GBP1.36 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 GBP1.36m.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
IR FMGMLVGLGLZM
(END) Dow Jones Newswires
September 11, 2019 02:00 ET (06:00 GMT)
Futura Medical (LSE:FUM)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Futura Medical (LSE:FUM)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024
