MAINSTAY MEDICAL INTERNATIONAL
Mainstay Medical International Plc: Mainstay Medical gibt Halbjahresergebnis für 2018 und
Geschäftsausblick bekannt
^
DGAP-News: Mainstay Medical International Plc / Schlagwort(e):
Halbjahresergebnis/Umsatzentwicklung
Mainstay Medical International Plc: Mainstay Medical gibt Halbjahresergebnis
für 2018 und Geschäftsausblick bekannt (News mit Zusatzmaterial)
21.09.2018 / 08:24
Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich.
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Mainstay Medical gibt Halbjahresergebnis für 2018 und Geschäftsausblick
bekannt
- Studie ReActiv8-B plangemäß - volle Datenergebnisse gegen Ende 2018
erwartet
- Finanzierungsrunde in Höhe von 37,5 Millionen US-Dollar (30 Millionen
Euro) für die Komplettierung der ReActiv8-B-Studie und die Ausweitung des
Vertriebs in Europa erfolgreich abgeschlossen
- Barmittelbestand 29,7 Millionen US-Dollar zum Stichtag 30. Juni 2018
Dublin - Irland, 21. September 2018 - Mainstay Medical International plc
("Mainstay", oder das "Unternehmen", Euronext Paris: MSTY.PA und Euronext
Dublin: MSTY.IE) gibt die Vorlage der Ergebnisse für das per 30. Juni
abgeschlossene erste Halbjahr 2018 bekannt und berichtet über die neueste
Geschäftsentwicklung. Das Medizintechnik-Unternehmen Mainstay vertreibt
ReActiv8(R), ein implantierbares wiederherstellendes
Neurostimulationssystem, das zur Behandlung von einschränkenden chronischen
Kreuzschmerzen (Chronic Low Back Pain, CLBP) ausgelegt ist.
Jason Hannon, der Vorstandsvorsitzende von Mainstay, sagte: "Die jüngste
Periode hat gezeigt, dass wir bedeutende Fortschritte über die gesamte
Breite des Geschäftes gemacht haben. Wir haben den Abschluss aller
Implantationen in der Studie ReActiv8-B bekannt gegeben und bleiben auf
gutem Weg, die vollständigen Daten Ende 2018 zur Verfügung zu haben. Das ist
ein bedeutender Schritt, unsere Bemühungen zu stärken, ReActiv8 den
Patienten in den USA zur Verfügung zu stellen.
"Wir konzentrieren uns darauf, schnelle Fortschritte in Deutschland zu
erzielen, in unserem ersten kommerziellen Markt. Von März an haben wir
unsere Vertriebsstrategie weiterentwickelt, unser Vertriebsteam neu
aufgestellt, uns auf die Fortbildung der neuen und vorhandenen
Teammitglieder fokussiert und unsere Ansprache potentieller implantierender
Ärzte verstärkt. Wir haben zudem einen neuen Geschäftsführer berufen, der
das Wachstum unseres Geschäfts in Deutschland, den Aufbau von Beziehungen zu
wichtigen Implanteuren sowie die Erweiterung unseres Teams mit erfahrenen
Vertriebsmitarbeitern verantwortet, die ReActiv8 schnell im Markt verbreiten
können.
In den vergangenen Monaten haben wir ermutigende Hinweise gesehen, dass
diese Initiativen Wirkung zeigen. Wichtig ist auch, dass wir bei unserem
Ziel, bis Jahresende zehn oder mehr ärztliche Partner zu gewinnen, die
mehrere Implantationen vorgenommen haben, auf Kurs bleiben. Wir glauben,
dass uns dieser Schwung für eine bedeutsamere geschäftliche Expansion im
Jahr 2019 gut aufstellt, während mehr Kunden die Therapie annehmen und
sicherer dabei werden, die richtigen Patienten auszuwählen. "
Business-Update
- Während der ersten Hälfte des Jahres 2018 machte Mainstays unter einer
Investigational Device Exemption (IDE) aufgelegte klinische Pivotalstudie
ReActiv8-B weiter entscheidende Fortschritte. Sie soll Daten gewinnen, die
Teil eines Pre-Market-Approval-Antrags (PMAA) bei der US Food and Drug
Administration (FDA) werden sollen. Dies ist ein entscheidender Schritt für
den Vertrieb von ReActiv8 in den USA. Der Abschluss aller Implantationen
wurde zu Beginn des dritten Quartals 2018 gemeldet. Insgesamt 204 Patienten
wurden im Rahmen der Studie implantiert, was das hohe Interesse
wiederspiegelt, an der Studie teilzunehmen. Der Abschluss der Implantationen
im Rahmen der Studie bedeutet, dass das Unternehmen auf einem guten Weg ist,
die vollständigen Daten gegen Ende 2018 bekannt zu geben.
- In Deutschland, Mainstays anfänglichem Europäischen Markt, wurde das
Vertriebsteam repositioniert, damit es bei seiner Arbeit besser auf wichtige
ärztliche Zielkunden fokussieren kann. Die Vertriebsmaßnahmen gemäß
dieser
Strategie begannen im März 2018 nach Abschluss der im Februar 2018
angekündigten Finanzierungsrunde, und greifen immer mehr. Die
Implantationsrate und die Zahl der neuen implantierenden Häuser sind im Juli
und August 2018 gegenüber den ersten sechs Monaten des Jahres stark
gestiegen.
- Wolfgang Frisch wurde am 20. Juni 2018 zum VP und Geschäftsführer für
Deutschland berufen. Er hat über 30 Jahre Erfahrung in der
Medizintechnikbranche und wird dazu beitragen, die Vertriebsstrategie weiter
voranzutreiben, mit Fokus auf die Übernahme der Therapie in einer
ausgewählten Zahl von Wirbelsäulenzentren mit hohem Patientenaufkommen zu
erreichen.
- Matthew Onaitis wurde per 20. August 2018 als Chief Financial Officer
berufen. Er bringt mehr als 20 Jahre Erfahrung in der Arbeit bei dynamischen
Gesundheitsunternehmen mit und hat tiefgehende Kenntnisse der Finanzierung
von innovativen Wachstumsunternehmen wie Mainstay.
Finanz-Update
- Am 15. Februar 2018 gab das Unternehmen den Abschluss einer
Finanzierungsrunde mit einem Volumen von 30,1 Million Euro (rund 37,5
Millionen US-Dollar) bekannt, die durch die Platzierung von 2.151.332 neuen
Stammaktien an neue und alte Aktionäre erfolgte. Die Finanzmittel werden für
den Abschluss der klinischen Studie ReActiv8-B, den Fortgang des
anfänglichen Vertriebs in Deutschland und anderen Märkten und für
Investitionen in frühe Vertriebsaktivitäten zur Vorbereitung des Marktstarts
in den USA verwendet.
- Die Erlöse in der per 30. Juni 2018 abgeschlossenen Sechsmonatsperiode
beliefen sich auf 0,4 Millionen US-Dollar (0,3 Millionen US-Dollar im ersten
Halbjahr 2017).
- Die betrieblichen Aufwendungen lagen bei 15,8 Millionen US-Dollar (12,3
Millionen US-Dollar im ersten Halbjahr 2017). Dieser Anstieg wurde vor allem
von den Kosten der Studie ReActiv8-B und der Vertriebsanstrengungen
getrieben.
- Der Barmittelbestand betrug 29,7 Millionen US-Dollar zum Stichtag 30. Juni
2018 (10 Millionen US-Dollar per 31. Dezember 2017).
Telefonkonferenz für Investoren
Der Vorstandsvorsitzende Jason Hannon und der Chief Executive Officer
Matthew Onaitis werden am 21. September 2018 um 14:00 MEZ eine
Telefonkonferenz einschließlich Frage- und Antwortrunde für Analysten und
Investoren abhalten. Die Telefonkonferenz wird in Englischer Sprache
ablaufen. Ein Mitschnitt wird 30 Tage lang zur Verfügung stehen. Die
Einwahlnummern der Telefonkonferenz sind wie folgt:
Europa: +44 333 300 0804
Irland: +353 1 431 1252
Frankreich: +33 170750711
Deutschland: +49 6913803430
USA: +1 6319131422
Teilnehmer-PIN: 87237611#
- Ende -
Über Mainstay
Mainstay ist ein Medizintechnik-Unternehmen mit dem Ziel, das innovative
implantierbare Neurostimulationssystem ReActiv8 für Menschen mit
einschränkenden chronischen Kreuzschmerzen (Chronic Low Back Pain, CLBP) zu
vertreiben. Das Unternehmen hat seinen Hauptsitz in Dublin, Irland. Es ist
mit Tochtergesellschaften in Irland, in den USA, in Australien, und in
Deutschland tätig. Seine Aktien sind zum Handel an der Börse Euronext Paris
(MSTY.PA) und am ESM der Euronext Dublin (MSTY.IE) zugelassen.
Über chronische Kreuzschmerzen
Eine der anerkannten Ursachen von chronischen Kreuzschmerzen (Chronic Low
Back Pain, CLBP) ist die gestörte Kontrolle des Nervensystems über die
Muskeln, die für die dynamische Stabilisierung der Wirbelsäule im unteren
Rücken zuständig sind. Eine instabile Wirbelsäule kann zu Rückenschmerzen
führen. ReActiv8 ist so konstruiert, dass es diejenigen Nerven elektrisch
stimuliert, die für die Kontraktion dieser Muskeln zuständig sind. Dadurch
hilft es, die Kontrolle über die Muskeln wieder herzustellen und die
dynamische Stabilisierung der Wirbelsäule zu verbessern, was dem Körper eine
Genesung von den chronischen Kreuzschmerzen erlaubt.
Menschen mit chronischen Kreuzschmerzen haben üblicherweise eine stark
reduzierte Lebensqualität und weisen erhöhte Werte bei Schmerz,
Einschränkungen, Depressionen, Angstzuständen und Schlafstörungen auf. Ihre
Schmerzen und Einschränkungen können trotz bester verfügbarer medizinischer
Behandlung fortbestehen. Nur ein kleiner Teil der Fälle lässt sich auf einen
pathologischen Befund oder einen anatomischen Defekt zurückführen, der mit
einem wirbelsäulenchirurgischen Eingriff korrigierbar wäre. Die Betroffenen
sind durch die Beschwerden in ihrer Arbeitsfähigkeit und Alltagstauglichkeit
stark eingeschränkt. Die Verluste an Arbeitstagen, Hilfeleistungen bei
Schwerbehinderung und Inanspruchnahme medizinischer Leistungen ist eine
erhebliche Belastung für den Einzelnen, seine Familie, die Wirtschaft, die
öffentliche Verwaltung und für die Allgemeinheit.
Weitere Einzelheiten finden sich unter www.mainstay-medical.com
ACHTUNG - in den USA ist ReActiv8 durch Bundesgesetze auf den Einsatz in der
Forschung beschränkt.
---
PR- und IR-Anfragen:
Consilium Strategic Communications (Internationale Strategische
Kommunikation, Wirtschafts- und Fachmedien)
Chris Gardner, Jessica Hodgson, Nicholas Brown
Tel: +44 203 709 5700 / +44 7921 697 654
Email: mainstaymedical@consilium-comms.com
FTI Consulting (für Irland)
Jonathan Neilan
Tel: +353 1 765 0886
Email: jonathan.neilan@fticonsulting.com
NewCap (für Frankreich)
Julie Coulot
Tél. : +33 1 44 71 20 40
Email: jcoulot@newcap.fr
AndreasBohne.Com/Kötting Consulting (für Deutschland)
Andreas Bohne
Tel : +49 2102 1485368
Email : abo@andreasbohne.com
Wilhelm Kötting
Tel: +49 69 75913293
Email: wkotting@gmail.com
Investor Relations:
LifeSci Advisors, LLC
Brian Ritchie
Tel: +1 (212) 915-2578
Email: britchie@lifesciadvisors.com
ESM Advisers:
Davy
Fergal Meegan oder Barry Murphy
Tel: +353 1 679 6363
Email: fergal.meegan@davy.ie or barry.murphy2@davy.ie
In die Zukunft gerichtete Aussagen
Diese Mitteilung enthält Aussagen, die in die Zukunft gerichtet sind oder so
verstanden werden könnten. Diese in die Zukunft gerichteten Aussagen sind
kenntlich durch Formulierungen, die in die Zukunft weisen, einschließlich
Ausdrücken wie "antizipiert", "glaubt", "schätzt", "erwartet",
"beabsichtigt", "mag", "plant", "projektiert", "sollte", "will" oder
"untersucht", oder jeweils durch deren negative oder andere Varianten, oder
durch vergleichbare Formulierungen, oder durch Darlegungen von Strategie,
Plänen, Planzielen, Zielsetzungen, künftigen Ereignissen oder Absichten.
Diese in die Zukunft gerichteten Aussagen schließen alles jenseits der
historischen Fakten ein. Sie sind Teil dieser Mitteilung und schließen
Absichten des Unternehmens, Überzeugungen oder gegenwärtige Erwartungen
unter anderem betreffend die Erlöse des Unternehmens, seine finanzielle
Lage, Vorstellungen, Finanzstrategien, Erwartungen an Produktentwurf oder
Entwicklung, regulatorische Anträge und Zulassungen, Erstattungsregelungen,
Kosten für Vermarktung und Marktdurchdringung sowie andere kommerzielle
Leistungen ein, sie sind aber darauf nicht beschränkt.
Es liegt in der Eigenart von in die Zukunft gerichteten Aussagen, dass sie
Risiken und Unwägbarkeiten einschließen, weil sie sich auf künftige
Ereignisse und Umstände beziehen. In die Zukunft gerichtete Aussagen sind
keine Garantien künftiger Leistungsfähigkeit, und die tatsächlichen
Ergebnisse der Tätigkeit des Unternehmens, die Entwicklung seines
Hauptproduktes, der Märkte und der Branche in der das Unternehmen tätig ist,
können wesentlich von jenen abweichen, die durch in die Zukunft gerichtete
Aussagen in dieser Mitteilung beschrieben oder angedeutet werden. Sogar wenn
die Ergebnisse der Tätigkeit des Unternehmens, seine finanzielle Lage und
sein Wachstum, sowie die Entwicklung seines Hauptproduktes, der Märkte und
der Branche, in der es tätig ist, mit den in dieser Mitteilung enthaltenen
in die Zukunft gerichteten Aussagen überein stimmen, sind diese Ergebnisse
oder Entwicklungen nicht unbedingt ein Hinweis auf Ergebnisse oder
Entwicklungen in Folgeperioden. Zahlreiche Faktoren könnten dafür sorgen,
dass Ergebnisse und Entwicklungen des Unternehmens erheblich von jenen
abweichen, die ausdrücklich oder implizit in den in die Zukunft gerichteten
Aussagen genannt sind. Das schließt uneingeschränkt den erfolgreichen
Marktstart und die Vermarktung von ReActiv8, den Fortschritt und Erfolg der
klinischen Studie ReActiv8-B, allgemeine wirtschaftliche und geschäftliche
Umstände, Bedingungen am weltweiten Medizintechnik-Markt, Branchentrends,
Wettbewerb, gesetzliche oder regulatorische Veränderungen, steuerliche
Veränderungen, die Verfügbarkeit und Kosten von Kapital, die zur Auflage und
zum Abschuss klinischer Studien benötigte Zeit, die zur Erlangung
regulatorischer Zulassungen erforderliche Zeit und Prozesse,
Wechselkursveränderungen, Veränderungen der Geschäftsstrategie sowie
politische und wirtschaftliche Unwägbarkeiten ein. Die hier genannten in die
Zukunft gerichteten Aussagen sind nur aussagekräftig zum Zeitpunkt dieser
Mitteilung.
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 or loss and other 9
comprehensive income
Condensed consolidated statement of financial position 10
Condensed consolidated statement of changes in shareholders' 11
equity
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 3rd Avenue,
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 J&E Davy
Broker
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 Caceis Corporate Trust
France)
1/3, Place Valhubert
75013 Paris, France
Mainstay Medical International plc
Interim 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(R),
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 plc
Directors' 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 plc
Condensed consolidated statement of profit or loss and other comprehensive
income
for the half year ended 30 June 2018
($'000) No- Half year Half year
te- ended 30 ended 30
s June 2018 June 2017
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 taxes (16,679) (13,144)
Income taxes 6 156 (131)
Loss for the half year (16,523) (13,275)
Net loss attributable to equity holders (16,523) (13,275)
Basic and diluted loss per share (in $) 5 (2.01) (2.01)
Other Comprehensive Income
Items that are or may be reclassified
subsequently to the statement of profit
or loss:
Foreign currency translation 56 (50)
differences of foreign operations
Total comprehensive loss for the half (16,467) (13,325)
year
Total comprehensive loss attributable (16,467) (13,325)
to equity holders
The accompanying notes form an integral part of these condensed consolidated
interim Financial Statements.
Mainstay Medical International plc
Condensed consolidated statement of financial position
at 30 June 2018
($'000) No- 30 June 31 December
tes 2018 2017
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 shareholders' 15,610 (5,821)
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 plc
Condensed consolidated statement of changes in shareholders' equity
for the half year ended 30 June 2018
($'000) Share Share Other Share based Retained Total
capi- premium reser- payment loss equity
tal ves reserve
Balance as at 64 106,360 4,735 4,606 (94,707) 21,058
1 January 2017
Loss for the - - - - (13,275) (13,275)
half year
Other - - (50) - - (50)
comprehensive
income for the
half year
Total - - (50) - (13,275) (13,325)
comprehensive
loss for the
half year
Transactions
with owners of
the Company:
Share based - - - 1,296 - 1,296
payments
Issue of - 4 - (3) 3 4
shares on
exercise of
share options
or warrants
Balance at 30 64 106,364 4,685 5,899 (107,979) 9,033
June 2017
(Unaudited)
Loss for the - - - - (16,560) (16,560)
half year
Other - - (92) - - (92)
comprehensive
income
Total - - (92) - (16,560) (16,652)
comprehensive
loss for the
half year
Transactions
with owners of
the Company:
Share based - - - 1,748 - 1,748
payments
Issue of - 50 - (34) 34 50
shares on
exercise of
share options
or warrants
Balance at 31 64 106,414 4,593 7,613 (124,505) (5,821)
December 2017
Loss for the - - - - (16,523) (16,523)
half year
Other - - 56 - - 56
comprehensive
income for the
half year
Total - - 56 - (16,523) (16,467)
comprehensive
loss for the
half year
Transactions
with owners of
the Company:
Share based - - - 1,852 - 1,852
payments
Issue of 3 37,483 - - (1,440) 36,046
shares
Balance at 30 67 143,897 4,649 9,465 (142,468) 15,610
June 2018
(Unaudited)
The accompanying notes form an integral part of these condensed consolidated
interim Financial Statements.
Mainstay Medical International plc
Condensed consolidated statement of cash flows
for the half year ended 30 June 2018
($'000) No- Half year ended Half year ended
tes 30 June 2018 30 June 2017
Unaudited Unaudited
Cash flow from operating
activities
Net loss for the half year (16,523) (13,275)
Add/(less) non-cash items
Depreciation 50 52
Finance income - (10)
Finance expense 1,018 986
Share-based compensation 10 1,852 1,296
Income taxes 6 (156) 131
Add/(less) changes in working
capital
Trade and other receivables (306) 12
Inventory (80) (831)
Trade and other payables 76 1,143
Taxes paid (112) (238)
Interest paid (603) (656)
Net cash used in operations (14,784) (11,390)
Cash flow from investing
activities
Acquisition of property and (26) (35)
equipment
Net cash used in investing (26) (35)
activities
Cash flow from financing
activities
Gross proceeds from issue of 37,486 4
shares
Transaction costs on issue of (1,440) -
shares
Repayment of borrowings 7 (1,500) (750)
Net cash inflow/(outflow) from 34,546 (746)
financing activities
Net increase/(decrease) in cash 19,736 (12,171)
and cash equivalents
Cash and cash equivalents at 9,975 36,670
beginning of year
Cash and cash equivalents at 30 29,711 24,499
June 2018
The accompanying notes form an integral part of these condensed consolidated
interim Financial Statements.
Mainstay Medical International plc
Notes to the condensed consolidated Financial Statements
1 General 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(R), an implantable restorative neurostimulation
system designed to treat an underlying casuse of disabling Chronic Low Back
Pain (CLBP).
2 Basis 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 $16,000, and we have not recognized any material
impairment losses at this time. The total outstanding balance as at 30 June
2018 was received post period end. Further information on the Group's credit
risk is detailed in Note 9. The Company measures loss allowances at an
amount equal to lifetime expected credit losses, except for cash which is
measured at 12-month expected credit losses. The maximum period considered
when estimating expected credit losses is the maximum contractual period of
exposure to credit risk.
c) Other new standards and interpretations
In addition, the Group applied the standards listed below for the first time
in the current period:
- IFRS 2 (amended) - Share Based Payments (effective 1 January 2018)
- Annual Improvements to IFRSs 2014 - 2016 Cycle: Amendments to IFRS 1 First
time Adoption
of IFRSs and IAS 28 Investment in Associates and Joint Ventures (IASB
effective date 1 January 2018, not yet endorsed by the EU)
- Transfers of Investment Property (Amendments to IAS 40) (effective 1
January 2018)
None of these have had any material impact on the Group's implementation of
accounting policies or on its reported results.
3 Segment reporting
Due to the nature of the Group's current activities, the Group considers
there to be one operating segment, Active Implantable Medical Devices
(AIMDs). The results of the Group are reported on a consolidated basis to
the Chief Operating Decision Maker of the Group, the Chief Executive
Officer. There are no reconciling items between the Group's reported
consolidated statement of profit or loss and other comprehensive income and
statement of financial position and the results of the AIMDs segment.
The Group has operations in Europe, the US and Australia. The non-current
assets held in these jurisdictions are detailed below:
($'000) 30 June 2018 31 December 2017
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:
($'000) Half year ended 30 Half year ended 30
June 2018 June 2017
Germany 250 231
Ireland 90 19
Other Europe 18 -
Total revenue by 358 250
country
4 Revenue
($'000) Half year ended 30 Half year ended 30
June 2018 June 2017
Revenue arising from the 358 250
sale of goods
358 250
5 Earnings per share
As the Group is incurring operating losses, there is no difference between
basic and diluted earnings per share.
Half year ended Half year ended
30 June 2018 30 June 2017
Weighted average number of 8,235,367 6,612,012
ordinary shares in issue
Loss per share 2.01 2.01
6 Taxes
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.
7 Interest 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 31 December
2018 2017
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 9,991 11,177
borrowings
Total loans and borrowings 13,173 14,391
8 Called 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 31 December
2018 EUR 2017 EUR
20,000,000 ordinary shares of EUR0.001 20,000 20,000
each
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 of EUR0.001 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).
9 Financial 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 £321,000.
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%.
10 Share 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: $1.3 million) is the grant date fair value of
various share options granted in the current and prior years, which are
being recognized within the statement of profit or loss and other
comprehensive income over the vesting period related to service. 279,878
options were granted in the six months ended 30 June 2018 (30 June 2017:
30,000 options).
11 Contingencies
The Directors and management are not aware of any contingencies that may
have a significant impact on the financial position of the Group.
12 Related party transactions
There were no balances due to or from related parties as at 30 June 2018 and
30 June 2017.
Key management compensation and Directors' remuneration
>The Group defines key management as its non-executive directors, executive
directors and senior management. Details of remuneration for key management
personnel for the six-month reporting period are provided below:
($'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
13 Events 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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Zusatzmaterial zur Meldung:
Dokument: http://n.eqs.com/c/fncls.ssp?u=MNVQGTKMFN
Dokumenttitel: Mainstay Medical gibt Halbjahresergebnis für 2018 und
Geschäftsausblick bekannt
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21.09.2018 Veröffentlichung einer Corporate News/Finanznachricht,
übermittelt durch DGAP - ein Service der EQS Group AG.
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725903 21.09.2018
°
Mainstay Medical International Plc: Mainstay Medical gibt Halbjahresergebnis für 2018 und Geschäftsausblick bekannt
Am 21. September 2018 um 08:26 Uhr
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