Regulatory News:

Mainstay Medical International plc (?Mainstay? ou ?La société?)
(Euronext Paris: MSTY.PA et ESM of the Irish Stock Exchange:
MSTY.IE) annonce ses résultats pour la période de six mois close le 30
juin 2014. Mainstay est une société irlandaise de dispositifs médicaux,
dont les activités sont basées en Irlande, en Australie et aux
Etats-Unis. La société se concentre sur le développement et la
commercialisation de ReActiv8, un dispositif de neurostimulation
implantable innovant conçu pour traiter les personnes atteintes de
lombalgie chronique, en les aidant à rétablir le contrôle des muscles
qui stabilisent la colonne lombaire.

Faits marquants

  • Une levée de fonds de 20.9 millions de dollars, nette de frais, a été
    réalisée par appel public à l?épargne. Ces fonds seront employés à
    faire progresser les essais cliniques avec pour objectif d?obtenir le
    marquage CE nécessaire à la commercialisation de ReActiv8 en Europe,
    et pour soutenir les besoins réglementaires aux Etats-Unis dans la
    préparation des essais cliniques requis en vue d?obtenir l?approbation
    des autorités américaines.
  • Les essais cliniques de ReActiv8-A progressent comme prévu. A la suite
    du lancement des essais cliniques en Australie, de nouveaux sites ont
    été ouverts en Belgique et en Angleterre.
  • Un dossier d?information de dispense de mise à l?essai d?un appareil
    expérimental (pre-IDE : pre-Investigational Device Exemption)
    a été soumis aux Etats-Unis à la Food and Drug Administration
    («FDA»). Suite aux commentaires de la FDA, la société prévoit de
    finaliser le protocole d’essais cliniques américains et de soumettre
    une demande à la FDA pour débuter un essai clinique sous IDE.
  • Les dépenses opérationnelles de 4.8 millions de dollars sont conformes
    aux prévisions.
  • Une position nette de trésorerie de 23.5 millions de dollars au 30
    juin 2014.

M. Peter Crosby, Président Directeur-Général de Mainstay, déclare : « L?appel
public à l?épargne et l?introduction en bourse en début d?année sont une
étape majeure du développement de Mainstay et nous sommes heureux de
l?élan donné pour permettre la commercialisation de ReActiv8. Les essais
cliniques se déroulent comme prévu et nous avons soumis notre dossier
pré-IDE à la FDA. Lorsqu?il sera disponible, ReActiv8 a le potentiel de
changer la vie de millions de personnes qui souffrent de lombalgie
chronique. »

Mainstay a également le plaisir d?annoncer la nomination de Tom Maher
aux postes de Directeur Juridique et de Secrétaire Général de la société
à compter du 2 septembre 2014. Tom possède une vaste expérience
juridique puisqu?il vient d?un grand cabinet d?avocats de Dublin, où il
était Associé au sein du département corporate et co-responsable
de la division Sciences de la vie. Tom a également précédemment occupé
les postes de Directeur Juridique et de Secrétaire Général chez Amarin
Corporation plc, une entreprise biopharmaceutique cotée au NASDAQ, et de
Vice-Président des Affaires juridiques chez Elan Corporation plc. Hugh
Kavanagh, qui occupe actuellement les rôles de Directeur Financier et de
Secrétaire Général de la société, poursuit son mandat de Directeur
Financier.

Mainstay Medical International plc

Interim management report

We are pleased to report on the progress of Mainstay Medical
International plc (?Mainstay? or the ?Company?) and present the
unaudited interim results of the Company and its subsidiaries (the
?Group?) for the six month period ended 30 June 2014.

Operations Update

Mainstay is developing innovative neurostimulation therapies for the
population of people with debilitating Chronic Low Back Pain. The Group
is focused on the development and commercialisation of an active
implantable medical device (AIMD) designed to treat Chronic Low Back
Pain by helping to restore control to the muscles that stabilise the
lumbar spine. The design of the Group?s first product, ReActiv8®,
has been completed and the planned clinical trial, ReActiv8-A, is under
way.

The purpose of the ReActiv8-A clinical trial is to investigate ReActiv8
as a treatment for adults with debilitating Chronic Low Back Pain for
whom surgery is not indicated. Since 31 December 2013, Mainstay has
continued to advance its activities for the ReActiv8-A clinical trial in
3 countries:

  • In March 2014 the Group secured approval from Ethics Committees in
    Australia to start the ReActiv8-A clinical trial and recruitment
    commenced at three sites in Australia. Subsequently a further site has
    been added in Australia.
  • In June 2014 Mainstay received authorisation from the Belgian Federal
    Agency for Medicines and Health Products and the Central Ethics
    Committee to expand the ReActiv8-A clinical trial to include two
    clinical trial sites in Belgium which are currently recruiting
    subjects. These two sites also participated in the Group?s European
    Feasibility Study, results of which were presented in mid-2013.
  • In July 2014 Mainstay received authorisation from the Medicines and
    Healthcare Products Regulatory Agency (?MHRA?) and the Central Ethics
    Committee to expand the ReActiv8-A clinical trial to include clinical
    trial sites in the United Kingdom.

In July Mainstay submitted a Pre-Investigational Device Exemption
information package to the US Food and Drug Administration (?FDA?) for
ReActiv8. Under the Pre-IDE Submission Program of the FDA, the Company
has requested feedback from the FDA prior to its planned ReActiv8 IDE
submission.

The Group is also continuing work to obtain CE Mark, which is required
for product commercialisation in Europe.

Corporate developments and financial update

The Company was incorporated and registered in Ireland on 17 February
2014 as a public limited company. Following a reorganisation on 3 April
2014, the Company became the ultimate holding company of the Group. The
Company together with its operating subsidiaries Mainstay Medical
Limited, MML US, Inc. and Mainstay Medical (Australia) Pty. Limited now
form the Mainstay Medical Group. Prior to this reorganisation Mainstay
Medical Limited had been the holding company of the Group.

Mainstay is at a pre-revenue stage. Operating expenses related to
on-going activities (excluding exceptional items) were $4.8 million
during the six months to 30 June 2014 (June 2013: $4.4m). Operating
expenses related to clinical trial activities, ongoing research and
development, and general and administrative expenses.

Net loss attributable to equity holders after exceptional items was
$75.9m (June 2013: $5.3m). This includes a non-cash exceptional item of
$66.5m associated with requirements under IFRS to ?fair value? financial
derivative instruments related to preference shares in issue prior to
the Company?s listing. All of these preference shares converted on a one
for one basis to ordinary shares immediately prior to the listing and
accordingly such fair value movements through comprehensive income will
not arise in future periods.

On 2 May 2014, the Company listed its ordinary shares on the ESM and
Euronext Paris. Total proceeds of $20.9 million (net of issue costs)
were raised by way of a capital increase in conjunction with the listing
of the entire issued ordinary share capital of the Company (the ?IPO?).
The proceeds will be used by Mainstay to fund clinical trial activities
to obtain CE Mark, which is required for initial commercialisation of
ReActiv8 in Europe.

Outlook and future developments

The Group looks forward to continuing progress with the ReActiv8-A
clinical trial as it moves towards obtaining CE Mark and initial
commercialisation of ReActiv8.

Principal risks and uncertainties

The principal risks and uncertainties faced by the Group over the
remaining six months of 2014 remain substantially unchanged from the
disclosures included in the IPO prospectus published by the Company on 9
April 2014 (the ?Prospectus?), which is available on the Company?s
website (www.mainstay-medical.com). Those risks are referred to on pages
17 to 19 of the Summary part of the Prospectus. These relate to the
clinical trial of ReActiv8 necessary to achieve CE Mark approval, and
general risks associated with any early-stage pre-revenue medical device
company, such as those relating to initial operating losses, on-going
funding requirements, intellectual property, liquidity, regulatory and
clinical matters, and reliance on a small number of key suppliers.

Auditors review

The condensed interim financial statements have not been reviewed by the
Company?s auditors.

On behalf of the board on 27August 2014,

Oern Stuge Peter Crosby
Chairman CEO

Mainstay Medical International plc

Directors? responsibility statement

Statement of the Directors in respect of the half-yearly financial
report

Each of the directors of the Company (the ?Directors?), whose names and
functions are listed in Corporate and Shareholder Information, confirm
that, to the best of each person?s knowledge and belief:

(a) the condensed interim financial statements comprising the condensed
consolidated statement of 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 15 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:

i. 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 set of financial statements; and a description
of the principal risks and uncertainties for the remaining six months of
the year; and

ii. 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.

Mainstay Medical International plc

Condensed consolidated statement of comprehensive income

for the half-year ended 30 June 2014

($’000) Notes Before exceptional items

2014

Exceptional items

2014

6 month period to 30 June 2014 6 month period to 30 June 2013
Unaudited Unaudited Unaudited Unaudited
Revenue
Operating expenses 3 (4,780) (4,780) (4,398)
IPO related expenses 4 (4,040) (4,040)
Operating loss (4,780) (4,040) (8,820) (4,398)
Finance income 20 20
Fair value (loss)/ gain on derivative financial instruments 4 (66,468) (66,468) 462
Finance expense (734) (734) (1,298)
Net finance expense (714) (66,468) (67,182) (836)
Loss before income taxes (5,494) (70,508) (76,002) (5,234)
Income taxes 10 (2) 96 94 (29)
Loss for the period and comprehensive loss for the period (5,496) (70,412) (75,908) (5,263)
Net loss attributable to equity holders (5,496) (70,412) (75,908) (5,263)
Basic and diluted loss per share (in $) 9 (3.54) (45.31) (48.85) (64.66)

Mainstay Medical International plc

Condensed consolidated statement of financial position

at 30 June 2014

($’000) Notes 30 June

2014

31 December 2013
Unaudited Audited
Non-current assets
Property, plant and equipment 71 68
Current assets
Prepayments and other receivables 1,155 385
Cash and cash equivalents 23,478 9,590
Total current assets 24,633 9,975
Total assets 24,704 10,043
Equity
Share capital 6 61 1
Share premium 6 72,584 250
Share based payment reserve 13 766 534
Other reserves 7 4,700 (9,609)
Retained loss (55,024) (13,146)
Surplus/(deficit) on shareholders’ equity 23,087 (21,970)
Non-current liabilities
Preference shares 24,965
Derivative financial instruments 4,622
Deferred tax 10 96
Total non-current liabilities 29,683
Current liabilities
Loans and borrowings 11 785
Trade and other payables 1,617 1,545
Total current liabilities 1,617 2,330
Total liabilities 1,617 32,013
Total equity and liabilities 24,704 10,043

Mainstay Medical International plc

Condensed consolidated statement of changes in shareholders? equity

for the half-year ended 30 June 2014

($’000) Share capital Share premium Capital conversion reserve Reorgani-sation reserve Share based payment reserve Retained loss Total equity
Unaudited
Balance at 1 January 2013 1 250 (9,609) 104 (2,828) (12,082)
Loss for the period (5,263) (5,263)
Share based payments 250 250
Balance at 30 June 2013 1 250 (9,609) 354 (8,091) (17,095)
Unaudited
Balance at 1 January 2014 1 250 (9,609) 534 (13,146) (21,970)
Loss for the period (75,908) (75,908)
Share based payments 232 232
Effect of reorganisation 55 879 (34,964) 34,030
Effect of IPO:
Issue of shares in Mainstay 1 23,922 23,923
Conversion of preference shares 4 47,533 49,273 96,810
Balance at 30 June 2014 61 72,584 49,273 (44,573) 766 (55,024) 23,087

Mainstay Medical International plc

Condensed consolidated statement of cash flows

for the half-year ended 30 June 2014

($’000) Notes 6 months period to 30 June 2014 6 months period to 30 June 2013
Unaudited Unaudited
Cash flow from operating activities
Net loss attributable to equity holders (75,908) (5,263)
Add/(less) non-cash items
Depreciation

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Mainstay Medical annonce ses résultats financiers semestriels

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