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2017 half-year results | Markets Insider


Regulatory News:


STENTYS (Paris:STNT) (FR0010949404 — STNT), a medical technology company
commercializing the first and only Self-Apposing® coronary stent, today
announces its half-year results to June 30, 2017, as approved by the
Board on September 29, 2017.


The 2017 half-year financial report is available on the Company’s
website, www.stentys.com,
under Investors / Filings / Accounts & financial reports (http://www.stentys.com/28/6/documents/documentation.html).


2017 first-half results















 

 

 

 

 


€ thousands – IFRS1


 

June 30, 2017

 

June 30, 2016

Revenues

 

3,548

 

3,644

Cost of goods sold

 

– 1,757

 

-1,490

Research & Development costs

-1,163

-1,979

Sales & Marketing costs

-2,177

-2,690

General & Administrative costs

 

-1,172

 

-1,430

Recurring operating loss (before share-based payment)

 

-2,721

 

-3,944

Other operating expenses and income (APPOSITION V)

0

3

Share-based payment

 

-95

 

-93

Operating loss

 

-2,817

 

-4,034

Net loss

 

-2,922

 

-4,107

 


In the first half of 2017, STENTYS’ key financial indicators progressed
as follows:


  • revenues totaled €3.5 million, a decrease of 2.6% compared with June
    30, 2016;

  • sales of the Company’s flagship product, the Xposition S stent, were
    up by +20% in volume and by +10% in value, compared with the first
    half of 2016 (combined effect of the price / geographical mix);

  • there was a 30% reduction in the operating loss to -€2.8 million, from
    -€4.0 million at June 30, 2016, thanks to a decrease in operating
    costs (-26% excluding cost of goods sold) resulting from the
    restructuring plan initiated during the second half of 2016.


In detail, operating costs broke down as follows:


  • cost of goods sold: the gross margin was 50.48% at June 30, 2017
    versus 59.12% at June 30, 2016 because of the combined effect of the
    price / product mix. However, it was up by 43 bp compared with
    December 31, 2016 (46.15%);

  • research & development costs: R&D spend totaled €1.2 million in the
    first half of 2017, versus €2.0 million in the same half of 2016. This
    was notably due to the closure of the American subsidiary at the end
    of 2016 and the effects of the Company’s operational restructuring
    initiated in the second half of 2016;

  • sales & marketing costs: the 19% decrease was mainly a result of the
    operational restructuring, notably on personnel costs, and the
    reduction of costs associated with clinical trials, including the
    completion of enrollment in the TRUNC trial;

  • general & administrative costs were in line with the cost-cutting plan
    implemented by the Company.


Financial structure


STENTYS had a cash position of €10.3 million at June 30, 2017, compared
with €12.4 million at March 31, 2017.


First-half highlights


  • Changes in the governance
    During the first half of the
    year, STENTYS appointed Mr. André Lerebours as Chief Financial Officer
    and Mr. Olivier Pierron as European Sales Director in charge of the
    direct sales force. The Shareholders Meeting of June 22, 2017 approved
    the appointment of two new independent Board members: Professor
    Christian Spaulding, Head of the Interventional Cardiology department
    at the Georges-Pompidou European Hospital, Paris, and Mrs. Sophie
    Baratte, Chief Executive Officer of medical technology company
    Cellnovo.

  • Follow-up results of two clinical studies presented at the annual
    EuroPCR meeting

    The follow-up data from the APPOSITION IV
    clinical trial at year 3 has confirmed the positive results initially
    observed: vessels treated with the STENTYS SES (Sirolimus-Eluting
    Stent) retain a stable lumen diameter and minimal late lumen loss
    (mean of 0.24 mm). The follow-up of the OPEN II clinical trial at year
    4, assessing the STENTYS first-generation self-apposing stent, has
    confirmed a low rate of major adverse cardiac events (MACE) with a
    slow progression.

  • Enrollment in the TRUNC trial completed
    At the end of
    July 2017, the Company announced that the enrollment of 200 patients
    in the TRUNC trial had been completed in line with the schedule. The
    results of this trial, which aims to evaluate the long-term safety and
    efficacy of the Xposition S stent for the treatment of the unprotected
    left main artery (the heart’s main artery), are expected before the
    end of 2018.


Christophe Lottin, Chief Executive Officer of STENTYS, says:The
restructuring plan that we initiated in the second half of 2016 has now
been completed. We are already seeing the first effects, with a
significant reduction in our operating loss. 2017 is a transformational
year for STENTYS, which will allow us to focus on the most dynamic
development routes, the main aim being to achieve a return to
sustainable growth. We are improving our product in order to increase
the gross margin while supplementing it with an efficient training
program for our new users. The specialized stent market on which we
operate offers tangible value-creation opportunities, and we intend to
eagerly seize these opportunities, both from a commercial perspective
and via a broadening of our product portfolio
.”


Upcoming financial publication


STENTYS will publish its revenues for the 3rd quarter of 2017
on Thursday October 12, 2017 after market.


About STENTYS


STENTYS is developing and commercializing innovative solutions for the
treatment of patients with complex artery disease. STENTYS’ Self-Apposing®
drug-eluting stents are designed to adapt to vessels with ambiguous or
fluctuating diameters in order to prevent the malapposition problems
associated with conventional stents. The APPOSITION clinical trials in
the treatment of acute myocardial infarction showed a very low one year
mortality rate and a faster arterial healing compared to conventional
stents. The company’s product portfolio also includes MiStent SES®,
a coronary DES whose new drug delivery mechanism is designed to match
vessel response, and is marketed through STENTYS’ commercial network in
Europe, the Middle East, Asia and Latin America. More information is
available at
www.stentys.com


STENTYS is listed on Compartment C of Euronext Paris
ISIN:
FR0010949404 – Ticker: STNT


Safe Harbor Statements


This press release contains forward-looking statements about the Company
that are based on numerous assumptions regarding the Company’s present
and future business strategies and the environment in which it will
operate in the future which may not be accurate. Such forward-looking
statements involve known and unknown risks which may cause the Company’s
actual results, performance or achievements to differ materially from
any future results, performance or achievements expressed or implied by
such forward-looking statements. Such factors include, among others,
risks associated with the development and commercialization of the
Company’s products, market acceptance of the Company’s products, its
ability to manage growth, the competitive environment in relation to its
business area and markets, its ability to enforce and protect its
patents and proprietary rights, uncertainties related to the U.S. FDA
approval process, slower than expected rates of patient recruitment for
clinical trials, the outcome of clinical trials, and other factors,
including those described in the Section 4 “Risk Factors” of the
Company’s 2015 Registration Document (document de référence)
filed with the French Autorité des Marchés Financiers (AMF) on
August 30, 2016 under number D.16-804.


1Half-year accounts have been the subject of a limited
review, and the limited auditor’s report is pending

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