TIDMIRSH
Mainstay Medical International plc ("Mainstay" or the "Company",
Euronext Paris: MSTY.PA and Euronext Dublin: MSTY.IE), a medical
device company focused on commercializing ReActiv8®, an implantable
restorative neurostimulation system designed to treat an underlying
cause of disabling Chronic Low Back Pain, today announces the
publication of its results for the Half Year ended 30 June 2018 and
provides a company update.
Jason Hannon, CEO of Mainstay, said: "The recent period has seen
us make significant progress across the business. We announced
completion of all implants in the ReActiv8-B study and remain on
track to have full data towards the end of 2018. This is a
significant step as we continue to build momentum in our efforts to
bring ReActiv8 to patients in the U.S.
"We are dedicated to making rapid progress in Germany, our first
commercial market. Starting in March of this year we refined our
commercial strategy, repositioned our sales team, focused the
training of our new and existing sales team members, and increased
our communication to potential implanting physicians. We also
appointed a new Managing Director with responsibility for growing
the commercial business in Germany, building relationships with key
implanting physicians, and growing our team with experienced sales
people who are capable of rapidly expanding ReActiv8 in the market.
In recent months we have seen encouraging signs that these
initiatives are working. Importantly, we remain on track to meet
our target of having 10 or more physician partners performing
multiple implants by the end of this year. We believe this momentum
will set us up for more meaningful commercial expansion in 2019 as
more customers begin to adopt and get comfortable with selecting
the appropriate patients for the therapy."
Business Update
-- During the first half of 2018, significant further progress was made
in Mainstay's pivotal IDE clinical study, ReActiv8-B, which
is
intended to gather data in support of a pre-market approval
(PMA)
application to the FDA, a key step towards the commercialization
of
ReActiv8 in the U.S. Completion of all implants was announced at
the
start of the third quarter of 2018. A total of 204 patients
were
implanted in the study, reflecting the strength of interest in
study
participation. The completion of implants in the clinical study
means
the Company remains on track to announce full data towards the
end of
2018.
-- In Germany, Mainstay's initial European market, the commercial team
was repositioned in order to better focus efforts on key
physician
targets. Commercialization efforts in line with this strategy
began in
earnest in March 2018, post our financing announced in February
2018,
and are gaining traction. The rates of implants and new
implanting
sites have increased sharply in July and August 2018 as compared
to
the first six months of the year.
-- Wolfgang Frisch was appointed VP and Managing Director for Germany on
20 June 2018. Mr. Frisch has over 30 years' experience in the
medical
technology industry and will be instrumental in continuing to
drive
the commercial strategy forward, with a focus on adoption in a
select
number of high volume spine care centers.
-- Matthew Onaitis was appointed Chief Financial Officer, effective 20
August 2018, bringing with him more than 20 years of
experience
working with dynamic healthcare businesses and deep knowledge
of
financing innovative growth companies like Mainstay.
Financial Update
-- On 15 February 2018, the Company announced the completion of a EUR30.1
million financing (approximately $37.5 million) through a
placement of
2,151,332 new ordinary shares to new and existing shareholders.
The
funds are being used to complete the ReActiv8-B clinical
study,
advance the initial commercialization of ReActiv8 in Germany and
other
markets and invest in early commercial activities in preparation
for
launch in the U.S.
-- Revenue during the six-month period ending 30 June 2018 was $0.4
million ($0.3 million in 1H17).
-- Operating expenses were $15.8 million ($12.3 million in 1H17). This
increase was driven primarily by costs relating to the
ReActiv8-B
study and associated with commercialization efforts.
-- Cash on hand at 30 June 2018 was $29.7 million (31 December 2017: $10
million).
Investor Conference Call
Jason Hannon, Chief Executive Officer, and Matthew Onaitis,
Chief Financial Officer, will host a conference call and Q&A
for analysts and investors at 13:00 BST (08:00 EDT, 14:00 CEST) on
21 September 2018. The call will be conducted in English and a
replay will be available for 30 days. Dial-in details for the call
are:
Europe: +44 333 300 0804
Ireland: +353 1 431 1252
France: +33 170750711
Germany: +49 6913803430
USA: +1 6319131422
Participant PIN: 87237611#
- End -
About Mainstay
Mainstay is a medical device company focused on commercializing
an innovative implantable restorative neurostimulation system,
ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP).
The Company is headquartered in Dublin, Ireland. It has
subsidiaries operating in Ireland, the United States, Australia,
Germany and the Netherlands, and is listed on the regulated market
of Euronext Paris (MSTY.PA) and the ESM of Euronext Dublin
(MSTY.IE).
About Chronic Low Back Pain
One of the recognized root causes of CLBP is impaired control by
the nervous system of the muscles that dynamically stabilize the
spine in the low back, and an unstable spine can lead to back pain.
ReActiv8 is designed to electrically stimulate the nerves
responsible for contracting these muscles and thereby help to
restore muscle control and improve dynamic spine stability,
allowing the body to recover from CLBP.
People with CLBP usually have a greatly reduced quality of life
and score significantly higher on scales for pain, disability,
depression, anxiety and sleep disorders. Their pain and disability
can persist despite the best available medical treatments, and only
a small percentage of cases result from an identified pathological
condition or anatomical defect that may be correctable with spine
surgery. Their ability to work or be productive is seriously
affected by the condition and the resulting days lost from work,
disability benefits and health resource utilization put a
significant burden on individuals, families, communities, industry
and governments.
Further information can be found at www.mainstay-medical.com
CAUTION - in the United States, ReActiv8 is limited by federal
law to investigational use only.
Mainstay Medical International plcPR and IR Enquiries:Consilium
Strategic Communications (international strategic communications -
business and trade media)Chris Gardner, Jessica Hodgson, Nicholas
BrownTel: +44 203 709 5700 / +44 7921 697 654Email:
mainstaymedical@consilium-comms.comorFTI Consulting (for
Ireland):Jonathan NeilanTel: +353 1 765 0886Email:
jonathan.neilan@fticonsulting.comorNewCap (for France)Julie
CoulotTel: +33 1 44 71 20 40Email:
jcoulot@newcap.frorAndreasBohne.Com/Kötting Consulting (for
Germany)Andreas BohneTel : +49 2102 1485368Email :
abo@andreasbohne.comorWilhelm KöttingTel: +49 69 75913293Email:
wkotting@gmail.comorInvestor Relations:LifeSci Advisors, LLCBrian
RitchieTel: + 1 (212) 915-2578Email:
britchie@lifesciadvisors.comorESM Advisers:DavyFergal Meegan or
Barry MurphyTel: +353 1 679 6363Email: fergal.meegan@davy.ie or
barry.murphy2@davy.ie
Forward looking statements
This announcement includes statements that are, or may be deemed
to be, forward looking statements. These forward looking statements
can be identified by the use of forward looking terminology,
including the terms "anticipates", "believes", "estimates",
"expects", "intends", "may", "plans", "projects", "should", "will",
or "explore" or, in each case, their negative or other variations
or comparable terminology, or by discussions of strategy, plans,
objectives, goals, future events or intentions. These forward
looking statements include all matters that are not historical
facts. They appear throughout this announcement and include, but
are not limited to, statements regarding the Company's intentions,
beliefs or current expectations concerning, among other things, the
Company's results of operations, financial position, prospects,
financing strategies, expectations for product design and
development, regulatory applications and approvals, reimbursement
arrangements, costs of sales and market penetration and other
commercial performance.
By their nature, forward looking statements involve risk and
uncertainty because they relate to future events and circumstances.
Forward looking statements are not guarantees of future performance
and the actual results of the Company's operations, and the
development of its main product, the markets and the industry in
which the Company operates, may differ materially from those
described in, or suggested by, the forward looking statements
contained in this announcement. In addition, even if the Company's
results of operations, financial position and growth, and the
development of its main product and the markets and the industry in
which the Company operates, are consistent with the forward looking
statements contained in this announcement, those results or
developments may not be indicative of results or developments in
subsequent periods. A number of factors could cause results and
developments of the Company to differ materially from those
expressed or implied by the forward looking statements including,
without limitation, the successful launch and commercialization of
ReActiv8, the progress and success of the ReActiv8-B Clinical
Study,general economic and business conditions, global medical
device market conditions,
industry trends, competition, changes in law or regulation,
changes in taxation regimes, the availability and cost of capital,
the time required to commence and complete clinical trials, the
time and process required to obtain regulatory approvals, currency
fluctuations, changes in its business strategy, and political and
economic uncertainty. The forward-looking statements herein speak
only at the date of this announcement.
Half Year Report
Mainstay Medical International plc and its subsidiaries
Half Year Report comprising Interim Management
Report and condensed consolidated
Financial Statements for the half year ended 30 June 2018
Mainstay Medical International plc
Table of contents
Corporate and shareholder information 3
Interim Management Report 4
Director's Responsibilities Statement 8
Condensed consolidated statement of profit 9
or loss and other comprehensive income
Condensed consolidated statement of financial position 10
Condensed consolidated statement of changes in shareholders' equity 11
Condensed consolidated statement of cash flows 12
Notes to the condensed consolidated Financial Statements 13
Forward looking statements
This report includes statements that are, or may be deemed to
be, forward looking statements. These forward looking statements
can be identified by the use of forward looking terminology,
including the terms "anticipates", "believes", "estimates",
"expects", "intends", "may", "plans", "projects", "should", "will",
or "explore" or, in each case, their negative or other variations
or comparable terminology, or by discussions of strategy, plans,
objectives, goals, future events or intentions. These forward
looking statements include all matters that are not historical
facts. They appear throughout this report and include, but are not
limited to, statements regarding the Company's intentions, beliefs
or current expectations concerning, among other things, the
Company's results of operations, including commercial performance,
financial position, prospects, financing strategies, expectations
for product design and development, regulatory applications and
approvals, commercialization plans, reimbursement arrangements,
costs of sales and market penetration.
By their nature, forward looking statements involve risk and
uncertainty because they relate to future events and circumstances.
Forward looking statements are not guarantees of future performance
and the actual results of the Company's operations, including
commercial performance, and the development of its main product,
the markets and the industry in which the Company operates, may
differ materially from those described in, or suggested by, the
forward looking statements contained in this report. In addition,
even if the Company's results of operations, commercial
performance, financial position and growth, and the development of
its main product and the markets and the industry in which the
Company operates, are consistent with the forward looking
statements contained in this report, those results or developments
may not be indicative of results or developments in subsequent
periods. A number of factors could cause results and developments
of the Company to differ materially from those expressed or implied
by the forward looking statements including, without limitation,
the successful launch and commercialization of ReActiv8, the
progress and success of the ReActiv8-B Clinical Trial, general
economic and business conditions, global medical device market
conditions, industry trends, competition, changes in law or
regulation, changes in taxation regimes, the availability and cost
of capital, the time required to commence and complete clinical
trials, the time and process required to obtain regulatory
approvals, currency fluctuations, changes in its business strategy,
and political and economic uncertainty. The forward-looking
statements herein speak only at the date of this report.
Mainstay Medical International plc
Corporate and shareholder information
Directors Oern Stuge MD, Independent
Non-Executive Chairman
Jason Hannon, Chief Executive Officer
and Executive Director
David Brabazon, Independent
Non-Executive Director
Greg Garfield, Non-Executive Director
Nael Karim Kassar, Non-Executive Director
Antoine Papiernik, Non-Executive Director
James Reinstein, Independent
Non-Executive Director
Manus Rogan PhD, Non-Executive Director
Dan Sachs MD, Non-Executive Director
Secretary Tom Maher
Registered office Clonmel House
Forster Way
Swords, K67F2K3
County Dublin, Ireland
Registered number 539688
Website www.mainstay-medical.com
ISIN / Symbol IE00BJYS1G50 / MSTY.PA (Paris) and MSTY.IE
Solicitors/ Lawyers McCann FitzGerald
Riverside One
Sir John Rogerson's Quay
Dublin 2, Ireland
Latham Watkins
885 3rdAvenue,
NY 10022, USA
Independent Auditor KPMG
Chartered Accountants
1 Stokes Place
St Stephen's Green
Dublin 2, Ireland
Principal Bankers HSBC
Bank of Ireland
ESM Adviser and Broker J&E Davy
Davy House
49 Dawson Street
Dublin 2, Ireland
Registrar Computershare Investor Services
(Ireland) Limited
Heron House
Corrig Road
Sandyford Industrial Estate
Dublin 18, Ireland
Paying Agent(in France) Caceis Corporate Trust
1/3, Place Valhubert
75013 Paris, France
Mainstay Medical International plcInterim Management Report
The Board of Directors is pleased to report on the progress of
Mainstay Medical International plc (Mainstay or the Company) and
present the Half Year Report for the half year ended 30 June 2018
of the Company and its subsidiaries (the Group or we).
Principal activities
Mainstay is a medical device company focused on commercializing
ReActiv8®, an implantable restorative neurostimulation system
designed to treat an underlying cause of disabling Chronic Low Back
Pain (CLBP). ReActiv8 is designed to electrically stimulate the
nerves responsible for contracting a muscle which stabilizes the
lumbar spine. Activation of this muscle to restore functional
stability has been shown to facilitate recovery from CLBP. Mainstay
received CE Marking for ReActiv8 based on positive results from the
ReActiv8-A Clinical Trial which demonstrated a statistically
significant and lasting improvement in pain, disability and quality
of life in people with disabling CLBP.
The Company is incorporated in Ireland as a public limited
company. The Company's ordinary shares are listed on the ESM of
Euronext Dublin and Euronext Paris.
As at 30 June 2018, the Company and its operating subsidiaries
Mainstay Medical Limited, MML US, Inc., Mainstay Medical
(Australia) Pty Limited, Mainstay Medical Distribution Limited,
Mainstay Medical B.V. and Mainstay Medical GmbH form the Mainstay
Medical Group.
Business review
ReActiv8-B Clinical Trial -The ReActiv8-B Clinical Trial (the
Trial) is an international, multi-center, prospective, randomized,
sham-controlled, triple blinded trial with one-way crossover,
conducted under an Investigational Device Exemption (IDE) from the
US Food and Drug Administration (FDA).
The Trial is intended to gather data in support of an
application for pre-market approval (PMA) from the FDA, a key step
towards the commercialization of ReActiv8 in the US. Information
about the trial can be found at
https://clinicaltrials.gov/ct2/show/study/NCT02577354.
The primary efficacy endpoint of the Trial is a comparison of
responder rates between the treatment and control arms. The Trial
will be considered a success if there is a statistically
significant difference in responder rates between the treatment and
control arms. The Trial, if successful, will provide Level 1
Evidence of efficacy of ReActiv8, which may be used to support
applications for reimbursement in the US. Data from the Trial will
also be used to support market development activities
worldwide.
In December 2017, the independent Data Monitoring Committee
(DMC) completed the pre-planned interim analysis of the Trial,
which was based on data from the first 58 patients in the pivotal
cohort to complete the primary endpoint. The DMC recommended
continuation of the Trial with a definitive size of 168 evaluable
patients. The DMC also reported that they had observed no safety
concerns in the Trial.
During the first half of 2018, significant further progress was
made to advance the Trial. In July 2018, we announced completion of
all implants in the Trial. Because of enrollment momentum at our
clinical sites at the time of and following the interim review of
the data, and reflecting the strength of interest in the Trial, a
total of 204 patients were implanted. The completion of implants in
the Trial means the Company remains on track to announce full data
towards the end of 2018.
Commercialization - In Germany, Mainstay's initial European
market, the commercial team was repositioned in order to better
focus efforts on key physician targets. Commercialization efforts
in line with this strategy began in earnest in March 2018, post our
financing announced in February 2018, and are gaining traction. Our
strategy is to focus on adoption in a select number of high volume
spine care centres. The rates of implants and new implanting sites
have increased sharply in July and August 2018 as compared to the
first six months of the year.
We have continued to add to our investment in commercial
infrastructure to expand commercialization in Europe, and in
preparation to enter other markets in the future. We will also
increase our investment in the training of physicians; the
education of referring physicians regarding the potential of
ReActiv8; and the collection and dissemination of clinical data
regarding use of ReActiv8.
Funding - On 15 February 2018, we announced the completion of a
EUR30.1 million financing (approximately $37.5 million) through a
placement of 2,151,332 new ordinary shares to new and existing
shareholders. On 4 May 2018, we announced the publication of a
prospectus (the Prospectus) in connection with the Placement. The
funds are being used to complete the ReActiv8-B Clinical Trial,
advance the initial commercialization of ReActiv8 in Germany and
other markets and invest in early commercial activities in
preparation for launch in the US. The Prospectus comprises a
Summary Document, a Securities Note and a Registration Document.
These documents are available on our website
(www.mainstay-medical.com).
ReActiv8-A Post Market Clinical Follow up (PMCF) Study - The
ReActiv8-A Clinical Trial was an international, multi-center,
prospective, single arm clinical trial of ReActiv8 that formed the
basis of our CE mark for ReActiv8.
Following CE marking approval, a range of activities is required
for post market clinical follow up to gather additional data on the
long-term performance and safety of ReActiv8. The ReActiv8-A PMCF
Study is a continuation of the ReActiv8-A Clinical Trial (but using
CE Marked ReActiv8). All subjects enrolled in the ReActiv8-A
Clinical Trial in Belgium and the UK are being converted to the
ReActiv8-A PMCF Study. Physicians commenced with these implants in
late 2017, and the full 40 implants are expected to be completed by
the end of 2018.
ReActiv8-C Registry - In addition to the ReActiv8-A PMCF Study,
the Company is maintaining the ReActiv8-C Registry, an
international, multi-centre data collection registry. All centres
that use the product commercially are invited to participate in the
Registry program. All patients who are implanted with ReActiv8 at
the centres participating in the Registry will be invited to enrol
in the Registry until the target enrolment numbers have been
reached. The purpose of the Registry is to gather additional
summary data on long term performance of ReActiv8 in at least 50
patients.
Financial review
Income Statement - Revenue during the six-month period ending 30
June 2018 was $0.36 million ($0.25 million during the same period
in 2017). Revenue was generated from sales of ReActiv8 systems to
customers in Germany and Ireland.
Operating expenses related to on-going activities were $15.8
million during the half year ended 30 June 2018 (same period in
2017: $12.3 million). On-going activities during the financial year
included research and development, clinical and regulatory
activities, selling, general and administrative activities.
Research and development expenses were $2 million during the
six-month period ended 30 June 2018, which is consistent with
expenditure of $2 million during the same period in 2017.
Expenditure during the 2018 period included the salaries of
engineers, technicians, and quality and regulatory specialists; the
cost of outsourced development and manufacturing activities;
biocompatibility and pre-clinical studies; and quality costs
including the maintenance of our quality system.
Clinical and regulatory expenses were $7.2 million during the
six-month period ended 30 June 2018 and increased by $2 million
from $5.2 million during the same period in 2017. This is primarily
driven by increased direct trial costs, consulting, training and
travel costs relating to activities for the Trial, which has sites
in the U.S., Australia and Europe.
Our selling, general and administrative expenses were $6.6
million during the six-month period ended 30 June 2018, and $5.1
million during the same period in 2017. The increase of $1.5
million is primarily driven by commercialization and the related
increase in our direct sales force (impacting recruitment fees,
payroll, travel and training costs), as well as marketing,
reimbursement consulting and market research costs. This increase
is also impacted by a non-cash expense for share options granted.
Selling, general and administrative expenses are expected to
increase in future years, as we increase our direct sales team to
drive activities to promote growth.
Statement of financial position - Total assets of the Group at
30 June 2018 were $33.6 million (31 December 2017: $13.3 million).
Cash on hand at 30 June 2018 was $29.7 million (31 December 2017:
$10 million). Cash used in operating activities was $14.8 million
during the period (30 June 2017: $11.4 million) and is reflective
of our increased operating expenses.
The Group's debt facility provided by IPF Partners was entered
into on 24 August 2015 for up to $15 million. The Group had drawn
down $4.5 million on 9 September 2015, $6 million on 3 December
2015 and $4.5 million on 28 July 2016. During 2018, the Group made
principal repayments of $1.5 million.
Since inception the Group has funded its operations primarily
through the issuance of equity securities and debt funding. The
Group continues to explore funding strategies (e.g., equity, debt,
partnering) to support its activities into the future, including
the possibility of a listing on NASDAQ or other US stock exchange
and a related public or other offer of securities.
Principal risks and uncertainties
The principal risks and uncertainties faced by the Group and/or
its industry for the remaining six months of 2018 remain
substantially unchanged from the risks disclosed in the Prospectus,
which is available on our website.
A summary of the principal risks relating to the Company and/or
its industry include the following:
-- We have incurred significant operating losses and may not be able to
achieve or subsequently maintain profitability.
-- We expect to require additional funds in the future in order to meet
our capital and expenditure needs and further financing may not
be
available when required or, if available, could require us to
agree to
terms which are specifically favourable to new investors, or
to
restrictions significantly limiting our access to additional
capital.
-- Our future financial performance is entirely dependent on the
commercial success of ReActiv8, our only product as of the date
of
this Report, obtaining adequate reimbursement for ReActiv8, and
rates
of product adoption and market penetration.
-- Failure to comply with debt covenants or failure to make repayments on
our debt facility could have a material adverse effect.
-- We operate in a highly regulated environment and regulatory approval
is required before we can market or sell ReActiv8 in any
market.
-- Seeking and obtaining regulatory approval for medical devices can be a
long and uncertain process. Strict or changing regulatory
regimes,
government policies and legislation in any of our target markets
may
delay, prohibit or reduce potential sales.
-- We are required to conduct clinical trials for regulatory approvals
and other purposes. Clinical trials carry substantial risks and
are
costly and time consuming, with uncertain results.
-- Any inability to fully protect and exploit our intellectual property
may adversely impact our financial condition, business,
prospects and
results of operations.
A more extensive description of the existing and future
potential risks to Mainstay's business and to the Company's
ordinary shares are outlined in the Risk Factors section of the
Prospectus, on pages 4 to 25, and should be considered carefully by
shareholders and prospective investors.
Outlook and future developments
During the first half of 2018, significant further progress was
made in Mainstay's pivotal IDE Clinical Trial, ReActiv8-B, which is
intended to gather data in support of a pre-market approval (PMA)
application to the FDA, a key step towards the commercialization of
ReActiv8 in the US. Completion of all implants was announced at the
start of the third quarter of 2018. The completion of implants in
the Trial means the Company remains on track to announce full data
towards the end of 2018.
If successful, the ReActiv8-B Clinical Trial will yield data in
support of an application for pre-market approval (PMA) from the
FDA. The data will also comprise Level 1 Evidence of efficacy,
which may be used to support applications for favorable
reimbursement in the US. Data from the ReActiv8-B Trial will also
be used to support market development activities worldwide.
Our refined commercialization strategy and repositioned
commercial team is gaining traction. Our strategy is to focus on
adoption in a select number of high volume spine care centers to
develop key reference sites, and then build on that experience and
data from the ReActiv8-B Trial to expand commercialization to
additional centers and other countries.
Related party transactions
Refer to note 12.
Going concern
The Directors have evaluated whether there are conditions and
events, considered in aggregate, that raise doubt about the Group's
ability to continue as a going concern within one year of the date
of issue of the consolidated financial statements. The Directors
note the following relevant matters:
-- The Group had cash of $29.7 million as at 30 June 2018 ($10 million as
at 31 December 2017).
-- The Group had operating cash out-flows of $14.8 million for the 6
months ended 30 June 2018 (year ended 31 December 2017: $24.9
million).
-- Due to the phase of development of the Group, the Group expects to
continue to incur losses in the medium term due to the
ongoing
investment in research and development, clinical and
commercial
activities.
-- The Group has an accumulated retained loss reserve of $142.5 million
and a reorganization reserve of $44.6 million as at 30 June 2018
(31
December 2017: $124.5 million and $44.6 million,
respectively).
-- The Group has funded operations to date through the proceeds of equity
funding of approximately $123.5 million and as at 30 June 2018,
debt
with an outstanding principal of $11.7 million.
In the event that additional funding is not secured in the 12
months from the approval of these Financial Statements, the
Directors believe that the Group has the ability, based on its
currently available cash resources, to consider alternative budgets
to manage its cash outflows so as to match those available cash
resources, to ensure that the Group will have sufficient funds to
be able to meet its liabilities as they fall due for a period of at
least 12 months from the date of the Financial Statements. On that
basis the Directors are satisfied that there is no substantial
doubt about the Group's ability to continue as a going concern and
that the Financial Statements should be prepared on a going concern
basis.
Auditors
The condensed consolidated Financial Statements have not been
reviewed by the Company's auditors.
Mainstay Medical International plcDirectors' responsibilities
statement
Statement of the Directors in respect of Half Year Financial
Report
Each of the Directors of the Company (the Directors), whose
names and functions are listed in the Corporate and Shareholder
Information, confirm that, to the best of each person's knowledge
and belief:
(a) the condensed consolidated Financial Statements comprising
the condensed consolidated statement of profit or loss and other
comprehensive income, the condensed consolidated statement of
financial position, the condensed consolidated statement of changes
in equity, the condensed consolidated statement of cash flows and
related notes 1 to 13 have been prepared in accordance with IAS 34
Interim Financial Reporting as adopted by the EU.
(b) the interim management report includes a fair review of the
information required by:
a. Regulation 8(2) of the Transparency (Directive 2004/109/EC)
Regulations 2007, being an indication of important events that have
occurred during the first six months of the financial year and
their impact on the condensed consolidated Financial Statements;
and a description of the principal risks and uncertainties for the
remaining six months of the year; and
b. Regulation 8(3) of the Transparency (Directive 2004/109/EC)
Regulations 2007, being related party transactions that have taken
place in the first six months of the current financial year and
that have materially affected the financial position or performance
of the entity during that period; and any changes in the related
party transactions described in the last annual report that could
do so.
On behalf of the Board on 19 September 2018,
Oern Stuge MD Jason Hannon
Chairman CEO
Mainstay Medical International plcCondensed consolidated
statement of profit or loss and other comprehensive incomefor the
half year ended 30 June 2018
($'000) Notes Half yearended Half yearended 30June 2017
30June 2018
Unaudited Unaudited
Revenue 4 358 250
Cost of sales (170) (136)
Gross profit 188 114
Operating expenses (15,849) (12,282)
Operating loss (15,661) (12,168)
Finance income - 10
Finance expense (1,018) (986)
Net finance expense (1,018) (976)
Loss before income (16,679) (13,144)
taxes
Income taxes 6 156 (131)
Loss for the half year (16,523) (13,275)
Net loss attributable (16,523) (13,275)
to equity holders
Basic and diluted loss 5 (2.01) (2.01)
per share (in $)
Other Comprehensive
Income
Items that are or may
be reclassified
subsequently
to thestatement of
profit or loss:
Foreign currency 56 (50)
translation
differences
of foreignoperations
Total comprehensive (16,467) (13,325)
loss
for the half year
Total comprehensive (16,467) (13,325)
loss attributable
to equity holders
The accompanying notes form an integral part of these condensed
consolidated interim Financial Statements.
Mainstay Medical International plcCondensed consolidated
statement of financial positionat 30 June 2018
($'000) Notes 30 June2018 31 December2017
Unaudited Audited
Non-current assets
Property, plant and equipment 177 201
Current assets
Inventory 2,474 2,395
Trade and other receivables 875 571
Income tax receivable 345 205
Cash and cash equivalents 29,711 9,975
Total current assets 33,405 13,146
Total assets 33,582 13,347
Equity
Share capital 8 67 64
Share premium 143,897 106,414
Other reserves 4,649 4,593
Share based payment reserve 9,465 7,613
Retained loss (142,468) (124,505)
Surplus/ (deficit) on 15,610 (5,821)
shareholders' equity
Non-current liabilities
Loans and borrowings 7 9,991 11,177
Total non-current liabilities 9,991 11,177
Current liabilities
Loans and borrowings 7 3,182 3,214
Income tax payable 12 124
Trade and other payables 4,787 4,653
Total current liabilities 7,981 7,991
Total liabilities 17,972 19,168
Total equity and liabilities 33,582 13,347
The accompanying notes form an integral part of these condensed
consolidated interim Financial Statements.
Mainstay Medical International plcCondensed consolidated
statement of changes in shareholders' equityfor the half year ended
30 June 2018
($'000) Sharecapital Sharepremium Otherreserves Sharebasedpaymentreserve Retainedloss Totalequity
Balance as at 64 106,360 4,735 4,606 (94,707) 21,058
1January
2017
Loss for the - - - - (13,275) (13,275)
half year
Other - - (50) - - (50)
comprehensiveincome
for the half year
Total comprehensive - - (50) - (13,275) (13,325)
lossfor
the half year
Transactions with
ownersof
the Company:
Share based - - - 1,296 - 1,296
payments
Issue of shares - 4 - (3) 3 4
onexercise of
share optionsor
warrants
Balance at 30 64 106,364 4,685 5,899 (107,979) 9,033
June2017
(Unaudited)
Loss for the - - - - (16,560) (16,560)
half year
Other - - (92) - - (92)
comprehensiveincome
Total comprehensive - - (92) - (16,560) (16,652)
lossfor
the half year
Transactions with
ownersof
the Company:
Share based - - - 1,748 - 1,748
payments
Issue of shares - 50 - (34) 34 50
onexercise of
share optionsor
warrants
Balance at 64 106,414 4,593 7,613 (124,505) (5,821)
31December
2017
Loss for the - - - - (16,523) (16,523)
half year
Other - - 56 - - 56
comprehensiveincome
for the half year
Total comprehensive - - 56 - (16,523) (16,467)
lossfor
the half year
Transactions with
ownersof
the Company:
Share based - - - 1,852 - 1,852
payments
Issue of shares 3 37,483 - - (1,440) 36,046
Balance at 30 67 143,897 4,649 9,465 (142,468) 15,610
June2018
(Unaudited)
The accompanying notes form an integral part of these condensed
consolidated interim Financial Statements.
Mainstay Medical International plcCondensed consolidated
statement of cash flowsfor the half year ended 30 June 2018
($'000) Notes Half yearended Half yearended 30June 2017
30June 2018
Unaudited Unaudited
Cash flow from
operating
activities
Net loss for the (16,523) (13,275)
half year
Add/(less) non-cash
items
Depreciation 50 52
Finance income - (10)
Finance expense 1,018 986
Share-based 10 1,852 1,296
compensation
Income taxes 6 (156) 131
Add/(less) changes
in working capital
Trade and other (306) 12
receivables
Inventory (80) (831)
Trade and other 76 1,143
payables
Taxes paid (112) (238)
Interest paid (603) (656)
Net cash used in (14,784) (11,390)
operations
Cash flow from
investing
activities
Acquisition of (26) (35)
property
and equipment
Net cash used (26) (35)
in investing
activities
Cash flow from
financing
activities
Gross proceeds from 37,486 4
issue of shares
Transaction costs on (1,440) -
issue of shares
Repayment of 7 (1,500) (750)
borrowings
Net 34,546 (746)
cash inflow/(outflow)
from
financingactivities
Net increase/(decrease) 19,736 (12,171)
in
cash
and cashequivalents
Cash and cash 9,975 36,670
equivalents
at beginning of year
Cash and cash 29,711 24,499
equivalents
at 30 June 2018
The accompanying notes form an integral part of these condensed
consolidated interim Financial Statements.
Mainstay Medical International plcNotes to the condensed
consolidated Financial Statements
1General information and reporting entity
Mainstay Medical International plc (the Company) is a company
incorporated and registered in Ireland. Details of the registered
office, the officers and advisers to the Company are presented on
the Corporate and Shareholder Information page.
The Half Year Report and condensed consolidated Financial
Statements for the periods ended 30 June 2018 and 30 June 2017
comprise the results of the Company and of its subsidiaries
(together the Group).
At 30 June 2018, the Group comprises the Company and its
operating subsidiaries Mainstay Medical Limited, Mainstay Medical
Distribution Limited, Mainstay Medical GmbH, Mainstay Medical B.V.,
MML US, Inc. and Mainstay Medical (Australia) Pty. Limited.
The Company's shares are quoted on Euronext Paris and the ESM of
Euronext Dublin.
Mainstay is a medical device company focused on developing and
commercializing ReActiv8®, an implantable restorative
neurostimulation system designed to treat an underlying cause of
disabling Chronic Low Back Pain (CLBP).
2Basis of preparation
Statement of compliance
The condensed consolidated Financial Statements have been
prepared in accordance with IAS 34 Interim Financial Reporting as
adopted by the EU. They do not include all the information and
disclosures necessary for a complete set of IFRS Financial
Statements. However, selected explanatory notes are included to
explain events and transactions that are significant to an
understanding of the changes in the Group's financial position and
performance since the last annual consolidated financial statements
as at and for the year ended 31 December 2017.
The comparative information provided in the condensed
consolidated Financial Statements relating to the periods ended 30
June 2017 and 31 December 2017 does not comprise the statutory
financial statements of the Group. Those statutory financial
statements for the year ended 31 December 2017 on which the
auditors gave an unqualified audit opinion, have been delivered to
the Companies Registry Office.
There are no significant or material changes to judgements or
estimates used in these condensed consolidated Financial Statements
compared with those used in the consolidated Financial Statements
for the year ended 31 December 2017.
The condensed consolidated Financial Statements were authorized
for issue by the Board of Directors, on 19 September 2018.
Going concern
The Directors have evaluated whether there are conditions and
events, considered in aggregate, that raise doubt about the Group's
ability to continue as a going concern within one year of the date
of issue of the consolidated financial statements. The Directors
note the following relevant matters:
-- The Group had cash of $29.7 million as at 30 June 2018 ($10 million as
at 31 December 2017).
-- The Group had operating cash out-flows of $14.8 million for the 6
months ended 30 June 2018 (year ended 31 December 2017: $24.9
million).
-- Due to the phase of development of the Group, the Group expects to
continue to incur losses in the medium term due to the
ongoing
investment in research and development, clinical and
commercial
activities.
-- The Group has an accumulated retained loss reserve of $142.5 million
and a reorganization reserve of $44.6 million as at 30 June 2018
(31
December 2017: $124.5 million and $44.6 million,
respectively).
-- The Group has funded operations to date through the proceeds of equity
funding of approximately $123.5 million and as at 30 June 2018,
debt
with an outstanding principal of $11.7 million.
In the event that additional funding is not secured in the 12
months from the approval of these Financial Statements, the
Directors believe that the Group has the ability, based on its
currently available cash resources, to consider alternative budgets
to manage its cash outflows so as to match those available cash
resources, to ensure that the Group will have sufficient funds to
be able to meet its liabilities as they fall due for a period of at
least 12 months from the date of the Financial Statements. On that
basis the Directors are satisfied that there is no substantial
doubt about the Group's ability to continue as a going concern and
that the Financial Statements should be prepared on a going concern
basis.
Currency
The condensed consolidated Financial Statements are presented in
US Dollars ($), which is the functional and presentational currency
of the Company. Balances in the condensed consolidated Financial
Statements are rounded to the nearest thousand ($'000) except where
otherwise indicated.
Basis of consolidation
The condensed consolidated Financial Statements comprise the
consolidated results of Mainstay Medical International plc and its
subsidiaries.
Significant accounting policies
With the exception of the newly implemented policies noted
below, the condensed consolidated Financial Statements have been
prepared applying the accounting policies that were applied in the
preparation of the Group's consolidated Financial Statements for
the year ended 31 December 2017, which were prepared in accordance
with IFRS and are available on the Company's website
(www.mainstay-medical.com) except as detailed below. These
accounting policies have been applied consistently for all periods
presented.
The Group has initially adopted IFRS 15 Revenue from Contracts
with Customers and IFRS 9 Financial Instruments from 1 January
2018. The implementation of these standards had no material impact
on the Group's reported results.
a)Revenue recognition
The Group has initially adopted IFRS 15 Revenue from Contracts
with Customers from 1 January 2018. Under IFRS 15, revenue is
measured based on the consideration specified in a contract with a
customer. The Group recognises revenue when it transfers control
over a product or service to a customer. This may arise on
shipment, delivery or in accordance with specific terms and
conditions agreed with customers and provided there are no material
remaining performance obligations required of the Group.
Revenue is measured at the fair consideration
received/receivable for the sale of goods to external customers net
of value added tax and discounts. Expected discounts are estimated
and provided for as a reduction in revenue based on agreements with
customers, agreed promotional arrangements and accumulated
experience. Accumulated experience is used to estimate and provide
for the discounts, using the expected value method, and revenue is
only recognised to the extent that it can be reliably measured and
when it is probable that future economic benefits of the
transaction will flow to the Group.
Service revenues (relating to training and implant support) are
recognized when the related services are rendered. When a customer
is invoiced, or cash is received but conditions for recognition of
the related revenues have not been met, revenue is deferred until
all conditions are met. The Group occasionally sells goods and
services as a bundled arrangement. Such sales are unbundled based
on the relative fair value of the individual goods and services
components and each component is recognized separately in
accordance with the Group's recognition policy.
Due to the stage of development of the Group, and the nature of
the Group's current activities (the Group has only one product,
ReActiv8, and some related accessories and services available for
sale), this new standard has not had a material impact on the Group
and there has been no restatement of previously reported
amounts.
b)Financial Instruments
The change in accounting policy to comply with the requirements
of IFRS 9 has had no impact on the amounts disclosed in the
financial statements other than immaterial changes to impairment of
trade and other receivables as discussed below. The changes in
classification of financial assets and liabilities to IFRS 9
classification has had no impact on the accounting for those assets
and liabilities.
Classification and measurement of financial assets and
liabilities
On initial recognition a financial asset is classified as
Measured at Amortised Cost, FVOCI or FVTPL. Financial assets are
not reclassified after initial recognition unless the related
business model changes. A financial asset is measured at amortised
cost if it is held in a business model whose objective is to hold
assets to collect contractual cashflows and its contractual terms
give rise on specific dates to cash flows that are solely payments
of principal or interest.
Trade and other receivables
Trade and other receivables are classified by the Group as
amortised cost assets under IFRS 9. These assets are recognised
initially at fair value. Subsequent to initial recognition, they
are measured at amortised cost using the effective interest method,
less any impairment losses.
Cash and cash equivalents
Cash and cash equivalents are classified by the Group as
amortised cost assets under IFRS 9. Cash and cash equivalents
comprise cash balances and call deposits with maturities of three
months or less, which are carried at amortised cost.
Trade and other payables
Trade and other payables are classified by the Group as other
financial liabilities under IFRS 9. These liabilities recognised
initially at fair value. Subsequent to initial recognition, they
are measured at amortised cost using the effective interest
method.
Interest-bearing borrowings
Interest-bearing borrowings are classified by the Group as other
financial liabilities under IFRS 9 and are recognised initially at
fair value including any attributable transaction costs. Subsequent
to initial recognition, interest-bearing borrowings are stated at
amortised cost using the effective interest method over the
contractual term.
Trade and other receivables and cash and cash equivalents were
previously classified as loans and receivables under IAS 39. There
has been no change in the classification of trade and other
payables or interest-bearing borrowings.
Impairment of financial assets
At each reporting date, in accordance with IFRS 9, the Group
assesses whether its financial assets, comprising of accounts
receivable and cash are impaired. The Group evaluates customer
accounts with past-due outstanding balances, and analyses customer
credit worthiness, payment patterns and trends. Based upon a review
of these accounts and management's analysis and judgement, we
estimate the future cash flows expected to be recovered from these
receivables. As at 30 June 2018, our trade and other receivables
balances amounted to $16,000, and we have not recognized any
material impairment losses at this time. The total outstanding
balance as at 30 June 2018 was received post period end. Further
information on the Group's credit risk is detailed in Note 9. The
Company measures loss allowances at an amount equal to lifetime
expected credit losses, except for cash which is measured at
12-month expected credit losses. The maximum period considered when
estimating expected credit losses is the maximum contractual period
of exposure to credit risk.
c)Other new standards and interpretations
In addition, the Group applied the standards listed below for
the first time in the current period:
-- IFRS 2 (amended) - Share Based Payments (effective 1 January 2018)
-- Annual Improvements to IFRSs 2014 - 2016 Cycle: Amendments to IFRS 1
First time Adoptionof IFRSs and IAS 28 Investment in
Associates
and Joint Ventures (IASB effective date 1 January 2018, not
yet
endorsed by the EU)
-- Transfers of Investment Property (Amendments to IAS 40) (effective 1
January 2018)
None of these have had any material impact on the Group's
implementation of accounting policies or on its reported
results.
3Segment reporting
Due to the nature of the Group's current activities, the Group
considers there to be one operating segment, Active Implantable
Medical Devices (AIMDs). The results of the Group are reported on a
consolidated basis to the Chief Operating Decision Maker of the
Group, the Chief Executive Officer. There are no reconciling items
between the Group's reported consolidated statement of profit or
loss and other comprehensive income and statement of financial
position and the results of the AIMDs segment.
The Group has operations in Europe, the US and Australia. The
non-current assets held in these jurisdictions are detailed
below:
($'000) 30 June 2018 31 December2017
Ireland 30 47
Germany 3 5
United States 144 149
Total non-current assets 177 201
The Group's total revenue by country is detailed below:
($'000) Half yearended Half yearended 30June 2017
30 June 2018
Germany 250 231
Ireland 90 19
Other Europe 18 -
Total revenue by country 358 250
4Revenue
($'000) Half year ended Half yearended30 June 2017
30 June 2018
Revenue arising from 358 250
the sale of goods
358 250
5Earnings per share
As the Group is incurring operating losses, there is no
difference between basic and diluted earnings per share.
Half yearended Half yearended30 June 2017
30 June 2018
Weighted average number of 8,235,367 6,612,012
ordinary shares in issue
Loss per share 2.01 2.01
6Taxes
Current income tax assets and liabilities for the current and
prior periods are measured at the amount expected to be recovered
from or paid to the relevant taxation authorities. The tax charge
has been prepared based on the Group's best estimate of the
weighted average tax rate that is expected for the full financial
year. The tax rates and tax laws used to compute the amount are
those used in Ireland, Germany, the Netherlands, the United States
and Australia.
7Interest bearing loans and borrowings
IPF Debt Financing
The Group's debt facility is secured by way of fixed and
floating charges over the assets and undertakings of Mainstay
Medical Limited, and the Mortgage Debenture includes customary
terms and conditions. In addition, Mainstay Medical International
plc has created a first fixed charge in favor of IPF over its
present and future shares held in Mainstay Medical Limited.
The terms of the agreement include a requirement that Mainstay
Medical Limited hold a minimum cash balance of $2 million or
achieve revenue targets within an agreed timeframe. The Group is
not in breach of any covenants at 30 June 2018 and has not been in
breach at any reporting date.
($'000) 30 June 2018 31 December2017
Loans and borrowings - current
Term loan 3,000 3,000
Deferred finance cost (90) (90)
Accrued interest 272 304
Total current loans and borrowings 3,182 3,214
Loans and borrowings - non-current
Term loan 8,700 10,200
Deferred finance cost (149) (194)
Accrued interest 1,440 1,171
Total non-current loans and borrowings 9,991 11,177
Total loans and borrowings 13,173 14,391
8Called up share capital
The Company's ordinary shares are quoted in Euro and have been
translated in US Dollars at the rates prevailing at the date of
issue.
Authorized and Issued Share Capital
Authorized 30 June 2018 31 December2017
EUR EUR
20,000,000 ordinary shares of EUR0.001 each 20,000 20,000
40,000 deferred shares of EUR1.00 each 40,000 40,000
60,000 60,000
Issued, called up and fully paid 2018 2017
$ $
8,770,229 (31 December 2017: 6,618,897) 11,240 8,562
ordinary shares ofEUR0.001 each
40,000 deferred shares of EUR1.00 each 55,268 55,268
66,508 63,830
In $'000 67 64
On 15 February 2018, Mainstay raised gross proceeds of EUR30.1
million (approximately $37.5 million) through a placement of
2,151,332 new ordinary shares. This issuance of new ordinary shares
was recorded in the Statement of Financial Position in USD at the
rate on the date of the transaction. Transaction costs directly
attributable to the issue of the new ordinary shares of
approximately $1.4 million have been offset against retained
earnings (in accordance with the Companies Act 2014).
9Financial instruments
Financial risk management
In terms of financial risks, the Group has exposure to credit
and financial risk, liquidity risk and market risk (comprising
foreign currency risk and interest rate risk). This note presents
information about the Group's exposure to each of the above risks
together with the Group's objectives, policies and processes for
measuring and managing those risks.
Risk management framework
Mainstay's Board of Directors has overall responsibility for the
establishment and oversight of the Group's risk management
framework. The Group's risk management policies are established to
identify and analyze the risks faced by the Group, to set
appropriate risk limits and controls and to monitor risks and
adherence to the limits. Risk management systems and policies will
be reviewed regularly as the Group expands its activities and
resource base to take account of changing conditions.
The Group has no significant concentrations of financial risk
other than concentration of cash with individual banks. The Group
is also exposed to credit risk arising on trade receivables, with
further information provided under credit risk below. There has
been no other significant change during the half year or since the
end of the half year to the types or quantum of financial risks
faced by the Group or the Group's approach to the management of
those risks.
Credit and financial risk
Credit risk is the risk of financial loss to the Group if a
customer or counterparty to a financial instrument fails to meet
contractual obligations and arises principally from the Group's
cash and cash equivalents and trade and other receivables. Credit
risk is managed on a Group basis. The maximum exposure to credit
risk is represented by the carrying amount of each asset. The
carrying value of receivables is a reasonable approximation of fair
value.
Trade receivables comprise of amounts due from customers, all of
which were current at 30 June 2018 and 31 December 2017. The
Company does not have exposure to significantly different
categories of customer and accordingly details of credit risk by
customer type or jurisdictions is not provided.
There were no material impairment losses recorded in the period
and the provision for expected credit losses at 30 June 2018 is
also immaterial. The carrying value of trade receivables of $16,000
at 30 June 2018 ($90,000 at 31 December 2017) represents the
maximum exposure to credit risk. The Group maintained its cash
balances with its principal financial institutions throughout the
year, and the Group limits its exposure to any one financial
institution by holding cash balances across several financial
institutions. The Group's principal financial institutions have
investment grade ratings at 30 June 2018. The credit rating status
of the Group's principal financial institutions is reviewed by the
Audit Committee or the Board annually. The cash balance is reported
to the Board of Directors on a monthly basis, and a monthly review
of all cash balances held at each institution is carried out by the
CFO. The Group maintains most of its cash in USD denominated
accounts. The Group held cash and cash equivalents of $29.7 million
as at 30 June 2018.
Liquidity risk
Liquidity risk is the risk that the Group will not be able to
meet its financial obligations as they fall due. Since inception
the Group has funded its operations primarily through the issuance
of equity securities and debt funding. The Group continues to
explore funding strategies (e.g., equity, debt, partnering) to
support its activities into the future, including the possibility
of a listing on NASDAQ or other US stock exchange and a related
public or other offer of securities. Adequate additional financing
may not be available on acceptable terms, or at all. The Group's
inability to raise capital as and when needed would have a negative
impact on the Group's financial position and its ability to pursue
its business strategy.
Foreign currency risk
The Group's reporting currency is the US Dollar. The Group's
exposure to foreign currency risk arises through expenditures
incurred in Euros, Great British Pounds (GBP) and Australian
Dollars.
The Group's Australian subsidiary has an Australian Dollar
functional currency and three of the Group's subsidiaries located
in Ireland, Germany and the Netherlands have a Euro functional
currency. Additionally, GBP expenditure is mainly incurred from the
UK based sites relating to the ReActiv8-A Post Market Clinical
Follow-Up ("PMCF") Study and U.S. Pivotal ReActiv8-B Clinical
Trial.
The Group did not have material asset or liability amounts in
foreign currencies at 30 June 2018 other than trade payables and
accruals (net of cash) of EUR1.2 million and GBP321,000.
Interest rate risk
The Group's cash balances are maintained in short term access
accounts and carry a floating rate of interest. A 50 basis points
change in the rate of interest applied to the cash balance held by
the Group would not have had a material impact on the Group's
statement of profit or loss in the half year ended.
At 30 June 2018, the principal outstanding on MML's loan from
IPF was $11,700,000. This loan carries a variable rate of 3-month
Euribor plus a margin ranging from 10.5% to 12.5%.
10Share based payments
Share Options
The terms and conditions of the Group's share option plan are
disclosed in the 2017 Annual Report. The charge of $1.9 million for
the half year ended 30 June 2018 (30 June 2017: $1.3 million) is
the grant date fair value of various share options granted in the
current and prior years, which are being recognized within the
statement of profit or loss and other comprehensive income over the
vesting period related to service. 279,878 options were granted in
the six months ended 30 June 2018 (30 June 2017: 30,000
options).
11Contingencies
The Directors and management are not aware of any contingencies
that may have a significant impact on the financial position of the
Group.
12Related party transactions
There were no balances due to or from related parties as at 30
June 2018 and 30 June 2017.
Key management compensation and Directors' remuneration
The Group defines key management as its non-executive directors,
executive directors and senior management. Details of remuneration
for key management personnel for the six-month reporting period are
provided below:
($'000) 30 June 2018 30 June 2017
Salaries 817 876
Non-executive directors' fees 135 111
Other remuneration 915 595
Payroll taxes 92 102
Share based payments 1,825 931
Pension 14 11
Total remuneration 3,798 2,626
13Events subsequent to 30 June 2018
There were no events subsequent to the half year ended 30 June
2018 that would have a material impact on the condensed
consolidated interim Financial Statements.
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